Enucleation

Kim, N.J., Choung, H.K., Khwarg, S.I., and Yu, Y.S.; “Free Orbital Fat Graft to Prevent Porous Polyethylene Orbital Implant Exposure in Patients with Retinoblastoma” Ophthalmic Plastic and Reconstructive Surgery, Vol. 21, No. 4, pp253-258 (July 2005)

Purpose: To determine if porous polyethylene orbital implant (MEDPOR®) exposure can be prevented in retinoblastoma patients when the implant is placed in combination with a free orbital fat graft over the anterior surface of the implant.

Methods: Free orbital fat grafts were preformed after enucleation and MEDPOR implantation, and results were compared with patients who underwent conventional enucleation and MEDPOR implantation without an orbital fat graft.

Results: Although implant exposure occurred in 13 of 39 eyes (33.3%) that had conventional enucleation and MEDPOR implantation, exposure did not develop in any of the 38 eyes that had the combined procedure with a free orbital fat graft.

Conclusions: These findings suggest that a free orbital fat graft is a simple, effective way to prevent orbital implant exposure in patients requiring enucleation and MEDPOR implantation.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Julian de Silva, D., Olver J.M.; “Hydroxypropyl Methylcellulose (HPMC) Lubricant Facilitates Insertion of Porous Spherical Orbital Implants,” Ophthalmic Plastic and Reconstructive Surgery, Vol. 21, No. 4 pp301-322

The insertion of an orbital implant in the posterior Tenon’s space or in the eviscerated sclera must be smooth, without entrapment or dragging of adjacent soft tissue. Anterior Tenon’s fascia and conjunctiva must be closed without undue tension that could lead to subsequent postoperative implant exposure. Current methods to prevent tissue drag include passing the implant via a cut “thumb” from a surgeon’s glove, the use of a prepackaged rigid plastic funnel, or a specialized orbital implant introducing forceps, e.g., Carter sphere injector. We also recommend coating the porous implant with an inert semi-synthetic viscoelastic polymer, thus enabling easy placement. We illustrate this in a typical case.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Hart, R.; Barnes, E.; Dickinson, A.J.; “Secondary Orbital Implants After Evisceration: A New Conjunctiva-Sparing Technique,” Ophthalmic Plastic and Reconstructive Surgery, Vol. 21 No. 2 pp129-132 (March 2005)

Purpose: To describe a new conjunctiva-sparing technique for secondary orbital implantation after evisceration.

Methods: Two patients with conjunctival cicatrization and a volume-deficient anophthalmic socket had implantation of an intraconal biointegratable implant. This was placed through a lateral canthal approach, after temporary disinsertion of the lateral rectus, thereby avoiding further injury to the conjunctival.

Results: A good surgical outcome was achieved in both patients. There were no intraoperative or postoperative complications, and both have remained stable for nearly 2 years.

Conclusions: Secondary intraconal implantation through the lateral canthal approach is safe and effective and suitable for patients in whom it is desirable to avoid a conjunctival incision.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Thakker, M.M., Fay A.M., Pieroth L., Rubin P.; “Fibrovascular Ingrowth Into Hydroxyapatite and Porous Polyethylene Orbital Implants Wrapped With Accellular Dermis”, Ophthalmic Plastic and Reconstructive Surgery, Vol 20, No 5, pp368-373 (2004)

Purpose: Acellular dermis is a frequently used wrapping material for hydroxyapatite (HA) and porous polyethylene (PP) orbital implants. In an animal model, we determined by histology the extent of fibrovascular ingrowth within orbital implants wrapped in acellular dermis at 6 and 12 weeks after surgery.

Methods: Four Yucatan minipigs were used for the study. Two minipigs had HA implants and two had PP implants. Implants were harvested at 6 or 12 weeks after surgery and were examined histologically for fibrovascular ingrowth.

Results: There was complete fibrovascularization of HA implants harvested at both 6 and 12 weeks after surgery. The PP implant harvested at 6 weeks had incomplete fibrovascularization, whereas the PP implant harvested at 12 weeks had complete fibrovascular ingrowth. There was no histologic evidence of inflammation seen in any of the orbital implants. On gross and histologic examination, the wraps were found to persist on the surface of all orbital implants, with little histologic evidence of inflammation localized to the acellular dermis.

Conclusions: Acellular dermis wraps support fibrovascularization of both HA and PP orbital implants. Additionally, acellular dermis does not incite significant inflammation in association with HA and PP orbital implants and can persist in situ for at least 12 weeks after surgery.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Perry, J.D., Tam, R.C., “Safety of Unwrapped Spherical Orbital Implants”, Ophthalmic Plastic and Reconstructive Surgery, Volume 20, Number 4, (2004)

Purpose: To determine the exposure rate of unwrapped spherical orbital implants after enucleation surgery.

Methods: Retrospective review of consecutive case series. All patients undergoing orbital implantation during enucleation surgery from October 1999 to September 2003 were included. Charts were reviewed for preoperative diagnoses, type and size of implant, use of a wrapping material, and complications.

Results: Twenty-six consecutive patients underwent enucleation surgery without wrapping material. Nineteen patients received porous polyethylene, five patients received polymethylmethacrylate, and two received hydroxyapatite. Mean implant diameter was 21.03 mm. Mean follow-up was 17.1 months (range, two to 43 months). There were no complications of implant extrusion, exposure, infection or migration.

Conclusions: The use of unwrapped spherical orbital implants may be associated with a low rate of early exposure. Careful choice of implant type may help reduce the risk of implant exposure.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Tawfik, H.A., Dutton, J.J., “Primary Peg Placement in Evisceration with the Spherical Porous Polyethylene Orbital Implant,” Ophthalmology, Volume 111, pp. 1401-1406 (2004)

Purpose: To determine the efficacy of primary placement of a motility coupling post (MCP) in evisceration with the porous polyethylene (PP) implant.

Design: Retrospective non-comparative, interventional case series.

Participants: Twenty patients undergoing evisceration.

Methods: A modified evisceration technique with porous polyethylene implants was performed, in which an MCP was placed primarily during the initial surgery. All patients were observed postoperatively for a minimum of 3 months.

Main Outcome Measures: Socket motility, final position of the MCP in the orbit, patient satisfaction.

Results: At the last follow-up visit, an acceptable range of motility was attained in all patients. Nineteen patients had a centrally positioned MCP, and all patients were pleased with the cosmetic outcome and the range of motility achieved. Minor complications were noted, including a mal-positioned MCP (n = 1) and poor motility in up-gaze (n = 8).

Conclusions: Primary peg placement at the time of evisceration with the PP implant is a promising technique with relatively minor complications so far, but properly constructed studies are required prospectively to compare motility with the MCP versus non-pegged implants.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Jordan, D.R., “Porous Orbital Implants and Evisceration Surgery: Experience With 86 Patients” Presented at the 2003 ASOPRS Scientific Symposium, Anaheim, California (November 15, 2003)

Situation: Porous orbital implants have become increasingly popular following enucleation, evisceration and during secondary orbital implant surgery. A variety of porous implants have appeared around the world since Dr. A. C. Perry introduced hydroxyapatite in the late 1980’s. The ones most commonly used in North America today include coralline hydroxyapatite, synthetic hydroxyapatite, porous polyethylene and aluminum oxide.

Methods: To assess the problems associated with evisceration surgery and porous implants, the author retrospectively reviewed the charts of 86 patients undergoing evisceration with one of the above porous implants between August 1991 and August 2002.

The following data was recorded: age, type of implant, type of surgery performed (standard evisceration or evisceration with posterior sclerotomies), size of implant used, peg system used, follow-up duration, time of pegging, problems and/or complications encountered and treatment.

Results: Eight patients had less than six (6) months follow-up, leaving 78 patients who were followed from six (6) to 107 months (average 31 months). Prior to peg placement, mild discharge occurred in six (6) (7.7%) patients, major discharge in two (2) (2.6%), implant exposure in six (6) (7.7%), broken implant in one (1) (0.3%). Peg problems occurred in 23 of 29 (79.3%) pegged patients. Problems encountered with the pegs were mild discharge in six (6) patients (20.6%); major discharge in seven (7) (24.1%); hydroxyapatite implant exposure around the sleeve in ten (10) (32.3%); pyogenic granulomas in three (3) (10.3%); loose sleeve in four (4) (13.7%); implant infection in two (2) (6.8%); peg falling out in one (1) (3.4%); accumulation of black material in one (1) (3.4%); chronic conjunctival edema in one (1) (3.4%); and sleeve shaft exposure in two (2) (6.8%).

Conclusion: In summary, although primary evisceration with posterior sclerotomies using a porous orbital implant (Bio-Eye™, FCI, synthetic HA, aluminum oxide, porous polyethylene) is a safe and effective method for treating a variety of end-stage eye diseases, patients should be cautioned about an increased likelihood of problems, should they consider pegging. Problems with pegging occurred in 23 of 29 (79.3%) pegged patients. In two (2) patients, post-pegging (6.8%) implant infection occurred with eventual implant removal.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Blaydon, S.M., Shepler, T.R., Neuhaus, R.W., White, W.L., Shore, J.W., “The Porous Polyethylene (MEDPOR®) Spherical Orbital Implant, A Retrospective Study of 136 Cases” Ophthalmic Plastic and Reconstructive Surgery, Vol. 19, No. 5, pp364-71 (2003)

Purpose: To evaluate complications and risk factors associated with the placement of wrapped and unwrapped porous polyethylene (PP) Spherical Implants after evisceration, enucleation, or secondary implantation.

Methods: A retrospective, interventional, noncomparative case series of consecutive cases of PP Implant placement after anophthalmic socket surgery performed by three surgeons over a five-year period. A PP Spherical Implant was placed in 133 patients, 61 women (two bilaterally) and 72 men (one bilaterally). There were 91 enucleations, 30 eviscerations, and 15 secondary implant placements. Sixty-six (48.5%) implants were wrapped prior to placement. Parameters evaluated included: age, sex, prior ocular surgery or radiation treatment, indications for surgery, procedure performed, size of PP Sphere, material used to wrap the implant, and complications.

Results: A total of 17 of 136 (12.5%) cases had documented postoperative complications, with implant exposure being the most common. In five patients (3.7%), implant exposure developed: 1 after evisceration and 4 after primary enucleation. Three of the five exposures were small and resolved with either observation alone or in one case with surgical revision of the socket. In two cases, the exposures were large enough that removal of the implant was indicated, one after evisceration and the other after enucleation with placement of a wrapped PP Sphere.

Conclusions: Our series revealed no significant difference in exposure rate between wrapped and unwrapped PP Sphere Implants, nor was the exposure rate affected by whether an eye was eviscerated or enucleated.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Custer, P.L., Kennedy, R.H., Woog, J.J., Kaltreider, S.A., Meyer, D.R., “Orbital Implants in Enucleation Surgery – A Report By The American Academy of Ophthalmology” Ophthalmology, Volume 110, pp. 2054-2061 (2003)

Objective: To compare prosthetic and implant motility and the incidence of complications associated with porous and non-porous enucleation implants.

Methods: Literature searches conducted in January 2002 for 1985 to 2001 and May 2002 for October 2001 to 2002 retrieved relevant citations. The searches were conducted in MEDLINE and limited to articles published in English with abstracts. Panel members reviewed the articles for relevance to the assessment questions, and those considered relevant were rated according to the strength of evidence.

Results: Arandomized clinical trial and a longitudinal cohort study detected no difference in implant or prosthetic movement between non-pegged hydroxyapatite porous and spherical alloplastic non-porous implants. No controlled studies were retrieved that investigated whether pegging porous implants improves prosthetic movement. Several case series indicate that patients with pegged hydroxyapatite implants have some degree of improved prosthetic motility. Longitudinal cohort studies show that sclera-covered hydroxyapatite implants have higher exposure rates than sclera-covered silicone implants, and unwrapped porous polyethylene implants have higher exposure rates than unwrapped acrylic implants. There are numerous case series that document a wide range of implant exposure rates in patients with various enucleation implants. It is difficult to compare complication rates among implant types because patient populations vary, surgical techniques differ, and follow-up periods are often limited.

Conclusion: Based on one randomized clinical trial, spherical alloplastic nonporous and nonpegged porous enucleation implants provide similar implant and prosthetic motility when they are implanted using similar surgical techniques. Coupling the prosthesis to a porous implant with a motility peg or post appears to improve prosthetic motility, but there are few available data in the literature that document the degree of the improvement. There is a widely variable incidence of porous implant exposure, but certain surgical techniques and the type of wrapping material seem to reduce the exposure rate. Additional research is needed to document the long-term incidence of complications related to porous enucleation implants and associated surgical techniques. This includes the use of wrapping materials and what procedural modifications, both surgical and prosthetic, are most effective in reducing these complications.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Anderson. R.L., Yen, M.T., Lucci, L.M., Caaruso, R.T. "The Quasi-Integrated Porous Polyethylene Orbital Implant", Ophthalmic Plastic and Reconstructive Surgery, Vol. 18, No. 1, pp 50-55 (2002)

Purpose: To describe a new quasi-integrated porous polyethylene orbital implant that combines the advantages of host tissue incorporation and improved motility with a single-stage surgery.

Methods: Twenty-four consecutive patients undergoing primary or secondary orbital implantation received the quasi-integrated porous polyethylene implant. Approximately 6 weeks after implantation, a custom-fitted prosthesis was made by an impression technique to provide a “lock-and-key” fit with the orbital implant. Post-operative complications and motility of the prosthetic shell were evaluated.

Results: During the 27-month period between December 1998 and March 2001, 24 patients received the quasi-integrated porous polyethylene implant as a buried orbital implant. Thirteen patients received the implant as a primary orbital implant after either evisceration or enucleation and 11 patients received the implant as a secondary orbital implant. Follow-up ranged from 3 months to 30 months, with an average of 16.9 months. All patients were considered to have good motility of their prosthetic shell at their final follow-up visit. No cases of implant extrusion or migration were noted. Two patients required deepening of their inferior fornix to accommodate the increased motility of their prosthesis.

Conclusion: The new quasi-integrated porous polyethylene orbital implant provides motility without the need for secondary placement of pegs or screws. It has the advantage of biocompatibility, allowing host tissue incorporation to resist implant migration and extrusion. The implant is available in three sizes: small, medium, and large, approximating the volume of a 16-, 18-, and 20-millimeter sphere.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Woog, J.J., Dresner, S., Lee, T.S., Kim, Y.D., Mandeville, J., Shore, J., Neuhaus, R., Amato, M. "The Smooth Anterior Surface Tunnel (SST) Porous Polyethylene Enucleation Implant", Poster presented at the Thirty-Second Annual Scientific Symposium of the ASOPRS, New Orleans, Louisiana (Fall 2001)

Purpose: To evaluate the safety and efficacy of a novel orbital implant design. The implant is composed of porous polyethylene with a smooth anterior surface with pre-drilled suture tunnels (SST) for attachment of extraocular muscles.

Methods: Fifteen nonrandomized patients undergoing enucleation surgery received the unwrapped SST orbital implant between February 2001 and September 2001.

Preliminary Results: Patients have been followed for 2 to 8 months. There have been no cases of intraoperative or postoperative complications, such as wound dehiscence, infection, or implant migration.

Conclusion: In preliminary studies, the SST orbital implant appears to be safe and to offer advantages over conventional implants. Further analysis is pending.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Kumar, V., Ainsworth, J.R., Willshaw, H.E. "Clinical Experience With High Density Porous Polyethylene (MEDPOR) Orbital Implants In Children", presented at The Association for Research in Vision and Ophthalmology Meeting, IVOS, Vol. 42, No. 4, 1850 - B100, March 15 (2001)

Purpose: The ideal implant for an anophthalmic socket should mimic the absent globe and be well tolerated. High-density porous polyethylene (MEDPOR) has many properties that make it a suitable material for use as an orbital implant. It is well tolerated because it is not antigenic, biologically inert, promotes tissue ingrowth and it does not become brittle with time. Reports of its use in children following enucleation for retinoblastoma are limited, but high rates of exposure in children receiving chemotherapy have been suggested. We have been using MEDPOR orbital implants following enucleation in children with retinoblastoma since 1995, and we present our experience in 30 consecutive patients.

Methods: All 30 patients receiving a MEDPOR Orbital Implant following enucleation for retinoblastoma from 1995 to 2000 were recruited. The following findings were documented: surgical complications, use of adjuvant therapies and implant exposure. Time to development, management and the long-term outcome of implant exposure were also recorded.

Results: Mean age at the time of implantation was 31 months (range 1 day - 108 months). Twenty-six (87%) of sockets underwent implantation at the time of enucleation and 4 (13%) had a secondary implant. Fourteen (47%) patients required adjuvant therapy (chemotherapy in 13, radiotherapy in 1). Twenty-five (83%) implants were 16mm or more in size. Mean follow-up after implantation was 25 months (range 3-60 months). No preoperative complications occurred. Implant exposure occurred in 3 (10%) patients. Mean time from implantation to exposure was 19 weeks (range 6-40 weeks). The rate of exposure in children requiring chemotherapy was 15% (2 of 13). In this group, exposure occurred following suture associated granuloma excision in one patient and post-operative orbital cellulitis in the other.

Conclusions: Contrary to previous reports we find MEDPOR Implant exposure to be low, and no more common than that associated with other implant materials. In addition we find no evidence that adjunctive chemotherapy appreciably increases the risk of implant exposure.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Acker, E.V., De Potter, P. "Porous Polyethylene Implant (MEDPOR®) Implant: Prospective Study Of 75 Primary Implantation Procedures", J Fr. Ophthalmol, Vol. 24, No. 10, pp 1067-1073 (2001)

Purpose: To examine the incidence of orbital complications in patients who underwent primary placement of a porous polyethylene implant (MEDPOR®) after enucleation.

Material and Method: Prospective non randomized case series of 75 consecutive patients in whom a porous polyethylene (PP) spherical implant wrapped with homologous sclera was implanted after enucleation.

Results: The mean age at the time of enucleation was 42.7 years (range 1.4 to 80 years). The histopathological diagnoses after enucleation included uveal melanoma in 28 patients, retinoblastoma in 11 patients, phthisis bulbi in 23 patients, neovascular glaucoma in 5 patients, endophthalmitis in 3 patients, ruptured traumatic globe in 2 patients, microphthalmos in two patients, and medulloepithelioma in one patient. Thirty-four patients (45%) had had prior ocular surgery. The prosthesis was fitted after a mean interval of 4.5 weeks (range 3 to 10 weeks). After a mean follow-up of 20 months (range, 3 to 33 months), there was one case (1%) of conjunctival dehiscence with material exposure secondary to massive postoperative orbital hemorrhage 2 weeks after enucleation. There was no case of orbital cellulitis, implant extrusion, or significant inflammatory response. No PP implant was drilled for peg placement.

Discussion-Conclusions: The anteriorly wrapped porous polyethylene orbital (MEDPOR®) Sphere appears to be well tolerated by all age groups with no major complication in primary implantation after enucleation.

Key Words: Polyethylene porous, orbital implant, enucleation.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Woo, K.I., Kim, Y. "Fibrovascular Ingrowth Into Anophthalmic Socket Implant Of Porous Polyethylene", presented at the European Society of Ophthalmic Plastic and Reconstructive Surgery 18th Meeting, Paris, France (September 14-16, 2000)

Introduction: A porous spherical anophthalmic socket implant has been widely used because it can provide many advantages including excellent motility of prosthesis. One of the most significant complications related with the porous anophthalmic implant is implant exposure. The effects of growth factors and modification of surgical procedures on fibrovascular ingrowth into anophthalmic socket implant were investigated.

Materials and methods: Enucleation followed by implantation of porous polyethylene spherical orbital implant without wrapping was performed on forty rabbits. The implant was not pretreated in group A. The implant was pretreated with normal saline in Group B; with bFGF in group C; with ECGS in group D; with VEGF in group E. Another sixteen rabbits using autogenous scleral wrapping were divided into two groups: BW group of saline-pretreated and CW group of BFGF-pretreated. The implant enucleation was performed at 1 or 2 weeks after implantation.

Results: Three kinds of growth factors could not enhance the fibrovascular ingrowth. The groups that used the implants pretreated with saline and unwrapped in autogenous sclera showed greater fibrovascular ingrowth into the implants.

Conclusions: Fibrovascular ingrowth into the anophthalmic socket implant in the early postoperative period was enhanced by modification of surgical procedures, such as application of saline-pretreated and unwrapped implants.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

De Potter, P., Duprez, T., Cosnard, G. "Postcontrast Magnetic Resonance Imaging Assessment Of Porous Polyethylene Orbital Implant (MEDPOR)", Ophthalmology, Vol. 107, No. 9, pp 1656-1660 (September 2000)

Objective: To evaluate the fibrovascular ingrowth progression within the porous polyethylene orbital implant (MEDPOR) with serial magnetic resonance imaging (MRI).

Design: Prospective, nonrandomized, comparative (self-controlled) trial.
Participants: Ten patients who underwent enucleation and implantation of a 20-mm porous polyethylene implant wrapped with heterologous sclera.

Methods: Serial precontrast and postcontrast T1-weighted MRI were obtained at 1.5, 3, 6, and 12 months after implantation. The percentage area of enhancement was calculated by use of manual; planimetric contouring unenhanced areas at the equator of each sphere on axial and coronal planes.

Results: All the implants showed enhancing areas as early as 1.5 months after enucleation. In 8 of the 10 patients, the areas of enhancement at the equator of the implant consistently showed similar centripetal progression primarily during the first 6 months after enucleation. The presence of fibrovascular tissue at the equator was associated in all cases with enhancing zones at the anterior portion of the implant. None of the implants showed diffuse complete enhancement after 12 months. Two patients failed to demonstrate further enhancement progression 1.5 months after implantation. No histopathologic study to equate with the MRI findings was performed in this series.

Conclusions: Postcontrast magnetic resonance studies seem to be the best-suited imaging modality for assessing the fibrovascular tissue progression into porous polyethylene spheres after enucleation and for identifying patients in whom failure of vascularization occurs. Incomplete vascularization at the equator of the porous polyethylene sphere does not prove an absence of fibrovascular ingrowth in the anterior region. Prior ocular surgery and coexisting arterial hypertension may slow the progression of fibrovascular ingrowth.

Dresner, S., Karesh, J.W. "Primary Implant Placement With Evisceration In Patients With Endophthalmitis", Ophthalmology, Vol. 107, No. 9, pp 1661-1665 (September 2000)

Objective: To evaluate the efficacy of primary orbital implant placement with evisceration in patients with endophthalmitis and blind eyes.

Design: Retrospective noncomparative case series.

Participants: Eleven patients with endophthalmitis and blind eyes underwent evisceration by two surgeons between 1994 and 1998.

Intervention: Evisceration and primary orbital implant placement.

Main Outcome Measures: All patients were evaluated for implant exposure and successful fitting of their prostheses.

Results: Ten of 11 patients had uneventful postoperative courses and successful prosthetic fitting. One patient with Pseudomonas aeruginosa endophthalmitis had an implant exposure successfully treated with a fascia lata patch.

Conclusions: Primary orbital implant placement with evisceration in patients with endophthalmitis is an acceptable treatment, eliminating the need for open evisceration and subsequent delayed orbital implant placement.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Rubin, M.D., Fay, A.M., Remulla, H.D. "Primary Placement Of A Motility Coupling Post In Polyethylene Orbital Implants", Arch Ophthalmol, Vol 118, pp 826-832 (June 2000)

The placement of a motility coupling post (MCP) to integrate the prosthesis with a porous orbital implant may enhance prosthetic motility following enucleation. Previously, MCP placement has required a second operation usually at least 6 months following enucleation. We developed a technique to place an MCP reliably and safely into a porous orbital implant at the time of enucleation. Eligibility criteria included high motivation to achieve maximal prosthetic motility, adequate conjunctiva to ensure desirable wound closure, and isolation of the 4 rectus muscles. Enucleation was performed in standard fashion with implantation of a conical porous polyethylene orbital implant. Implanted MCPs protruded anteriorly 2 to 4 mm. The Tenon capsule and conjunctiva were closed in separate layers over the protruding MCP. Thirty-two patients underwent primary placement. Follow-up ranged from 1 to 33 months (mean 15 months). Nine MCPs spontaneously exposed within the first 4 months. One additional post autoexposed at 12 months. Three patients underwent a secondary procedure to expose the MCP. There were no cases of infection, explantation, or gross MCP malposition. Minor complications included pyogenic granuloma (n=2) and conjunctival overgrowth (n=1). All patients were successfully fit with prostheses. Prosthetic motility was acceptable in all patients. Motility coupling post placement at the time of enucleation surgery in selected patients is an effective, efficient surgical option.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Bigham, W.J., Stanley, P., Cahill, J.M., Curran, R.W., Perry A.C. "Fibrovascular Ingrowth In Porous Ocular Implants: the Effect Of Material Composition, Porosity, Growth Factors, And Coatings", Ophthalmic Plastic and Reconstructive Surgery, Vol., No. 5, pp 317-325 (September 1999)

Purpose: Fibrovascular ingrowth into various porous ocular implants as a function of implant material composition, porosity, growth factors, and coatings was investigated in a pilot study in an animal model.

Methods: Eighty-one New Zealand white rabbits underwent unilateral enucleation and implantation with ocular implants composed of the following materials: coralline hydroxyapatite (HA) with 200-mm pores (HA200) or 500-mm pores (HA500), synthetic HA (synHA), and high-density porous polyethylene (PP). The HA200, HA500, and PP implants were implanted untreated or after treatment with recombinant human basic fibroblast growth factor (Rh-bFGF). Nine HA500 implants were implanted after coating with calcium sulfate (plaster of Paris) to provide a smooth outer surface. Implants were harvested at 1-, 2-, 4-, or 8-week intervals and were examined histologically.

Results: A significant difference was found between untreated HA500 and PP, with PP showing better ingrowth. There was no significant difference between untreated HA and PP, nor between untreated HA500 and synHA. Significant increases in ingrowth were found in HA200 compared with HA500, and in Rh-bFGF-treated implants compared with untreated controls. The calcium sulfate-coated implants showed less vascularization compared with the uncoated implants, although the difference was not significant.

Conclusions: Fibrovascular ingrowth occurred earlier in HA200 implants than in HA500 implants, and was enhanced when implants were treated with Rh-bFGF.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Massry, G.G.*, Holds, J.B.** "Frontal Periosteum As An Exposed Orbital Implant Cover", Ophthalmic Plastic and Reconstructive Surgery, Vol. 15, No. 2, pp 79-82 (1999). *Sinskey Eye Institute, Santa Monica, California and **Department of Ophthalmology, Saint Louis University Health Sciences Center, Saint Louis, Missouri, U.S.A.

Purpose: To describe the surgical technique of harvesting frontal bone periosteum, through an eyelid-crease incision, for coverage of orbital implants.

Methods: A retrospective review of the medical records of 15 patients who underwent the procedure.

Results: Eleven patients had surgery to cover exposed orbital implants, whereas in 4 patients the periosteal graft was used as an implant cover during enucleation. Periosteal grafts as large as 25mm in diameter can be harvested. Recurrent exposure developed in 2 patients who had complicated histories of local trauma. One of these patients required a secondary dermis-fat graft and the other experienced spontaneous granulation. The remaining 13 patients had excellent results without complications.

Conclusion: Harvesting frontal bone periosteum, through an eyelid-crease incision, for orbital implant coverage is a relatively straightforward surgical technique. The procedure can be performed in the office under local anesthesia and yields excellent results. Recurrent exposure occurred only in 2 patients with histories of significant local trauma.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Dresner, S.C., Murphree, A.L., Karesh, J.W. "Conical Porous Polyethylene Implants For Enucleation And Evisceration", presented at the American Society Surgeons Meeting, New Orleans, Louisiana, U.S.A. (Fall 1998)

High density porous polyethylene implants have been used successfully in the management of cosmetic and post-traumatic facial deformities, orbital trauma and as an implant in anophthalmic socket surgery. This material is well tolerated, resists infection and is non-antigenic and promotes tissue ingrowth. Integration of these implants has also been documented.

Superior sulcus deformities are common in the anophthalmic socket because of inadequate volume replacement with standard orbital implants, rotational changes in the socket and possibly by orbital fat atrophy. The CVA™ implant addresses these concerns; however, its shape and design are not useful for evisceration or secondary implantation.

A new conical high density porous polyethylene implant has been designed, which is useful in enucleation, evisceration and secondary implantation. Thirty-three patients received these implants over a four-year period. There were twenty-three enucleations, eight eviscerations and two secondary implants. Ages ranged between seven months and 81 years of age. There was one implant exposure. Postoperative enophthalmos was minimized and there was good to excellent motility in all patients.

This new conical porous polyethylene implant (MCOI, Porex Surgical Inc.) has a flattened anterior surface to help preserve the fornices. These implants can also be used universally in enucleation, evisceration and improved prosthesis fitting with and without motility coupling devices.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Rubin, P.A.D., Popham, J., Rumelt, S, Remulla, H., Bilyk, J.R., Holds, J., Mannor, G., Maus, M., Patrinely, J. "Enhancement Of The Cosmetic And Functional Outcome Of Enucleation With The Conical Orbital Implant", Ophthalmology, Vol. 105, No. 5, pp 919-925 (May 1998)

The authors evaluated a new design of a conical-shaped enucleation implant to help minimize the occurrence of superior sulcus defects and maximize motility of the prosthesis. The implant shape is a modification of a sphere. It has a posterior conical projection paralleling the orbital walls, a superior projection supporting the soft tissues of the upper eyelid sulcus, a flattened anterior surface and channels for each rectus muscle.

A total of 43 patients had minimal or no superior sulcus defect, whereas 2 patients had moderate defects. There were no severe sulcus defects. All patients were satisfied with their appearance and did not seek further surgery to correct any upper sulcus asymmetry. Prosthetic motility with small-angle ductions (<10 degrees ) and saccades was good in all cases. There were two cases of conjunctival wound dehiscence. Both occurred within 4 weeks of surgery. One wound dehiscence was sutured, whereas the other healed spontaneously. There were no cases of implant extrusion, migration, or infection.

The conical orbital implant provides appropriate reconstitution of orbital volume while minimizing superior sulcus defects with adequate prosthetic motility.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Jahrling E.R. "Fitting the MEDPOR® Motility Coupling Post (MCP)", Journal of Ophthalmic Prosthetics (Official Journal of the American Society of Ocularists), Vol. 2, No. 1, pp 47 - 53 (Fall 1997)

Rubin, P.A.D., Green, J.P., Kent, C., Shore, J.W. "MEDPOR® Motility Coupling Post: Primary Placement In Humans", presented at the American Society of Oculoplastic and Reconstructive Surgeons Annual Meeting, San Francisco, California, U.S.A. (Fall 1997)

To demonstrate the safety and efficacy of primary placement of the MEDPOR® Motility Coupling Post (MCP) on the anterior surface of MEDPOR Orbital Implants at the time of enucleation.

Previous animal (rabbit) studies have demonstrated that a titanium screw placed within a MEDPOR enucleation implant is well tolerated, exhibits minimal inflammation, no inhibition of vascularization and no inducement of implant exposure. We sought to extend this model to placement of the post at the time of enucleation; covering the peg deep to conjunctiva and within Tenons capsule, with plans to expose the post three to six months post-operatively. The pursuit of this study was based on: 1) our observation that the front, flat surface of the conical orbital implant does not migrate significantly from the intraoperative to final post-operative position, 2) an extension of the procedure applied for osseointegrated implants in which a titanium implant is buried, then externalized, at a later date, following appropriate vascularization of the wound bed.

Conical MEDPOR Orbital Implants covered with autogenous fascia lata were placed in anophthalmic sockets of humans immediately following standard enucleation. The four recti muscles were secured to the implant and the central, anterior portion of the implant, noted at the intersection between the horizontal and vertical muscle channels, were marked and treated with a light bipolar cautery. Using a hand drill, a pilot hole was placed followed by the titanium Motility Coupling Post (MCP) manufactured by Porex Surgical Inc. The head of the MCP was positioned 2-3mm above the surface of the implant. Tenons capsule and conjunctiva were meticulously closed with minimal tension. Great care was taken to position the suture line away from the MCP to avoid induced pressure at the wound closure site. Patients who did not have spontaneous exposure of the MCP were scheduled to undergo a conjunctival cutdown procedure over the protruding MCP 2-6 months post-operatively.

Ten patients were treated in the above fashion. Follow-up ranged from 3 to 12 months. Four of the titanium posts were found to have exposed spontaneously at 2-4 weeks following original surgery. These four patients had no complications and did not require a conjunctival cutdown to expose the implant later. The border of vascularized conjunctiva grew right up to the surface of the MCP. There were no wound dehiscences, infections, or malpositions of the MCP. The patients were fit with an MCP coupled prosthesis 8 weeks post-operatively. Motility of the patients with the MCP was improved following MCP placement and was greater than the motility in other patients without a MCP.

Primary placement of a titanium MCP can be performed in human patients when using MEDPOR Conical Orbital Implants at the time of enucleation. Ten patients underwent this procedure with a follow-up of 3-12 months without any untoward results. Four of the eight patients had an unexpected, but fortunate result of spontaneous exposure of the MCP without a conjunctival cutdown. As this procedure can accomplish coupling of the implant to the prosthesis without the need for a secondary procedure, patient acceptance is high and total operating costs are reduced.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Choi, J.C., Rubin, P.A.D., Popham, J.K., Iwamoto, M.A., Shore, J.W. "MEDPOR® Motility Coupling Post: A New Coupling Device for MEDPOR Orbital Implants", presented at the American Society of Oculoplastic and Reconstructive Surgeons Annual Meeting, Chicago, Illinois, U.S.A. (October 1996)

In our practices, many patiens have recieved porous polyethylene orbital implants (PPOI) following enucleation. As an implant which promotes fibrovascular ingrowth, PPOI poses as an excellent candidate for accommodating an indwelling coupling device.

We have investigated the feasibility of coupling the PPOI with an ocular prosthesis. In collaboration with Porex Surgical Inc., we developed a titanium coupling device, the Motility Coupling Post (MCP).

The MCP is a surgical grade titanium screw with a head height of 4 mm and the body length of 6 mm. It is screwed into the vascularized PPOI after a hole has been drilled. A precision fixation clamp holds the PPOI securely as the hole is drilled. Drilling is accomplished under local anesthesia in a treatment room or an office setting. The head of the MCP remains exposed and the conjunctiva heals around the exposed head of the MCP. The posterior surface of ocular prosthesis is modified and coupled witht he head of the MCP.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Choi, J.C., Iwamoto, M.A., Bstandig, S., Rubin, P.A.D., Shore, J.W. "MEDPOR® Motility Coupling Post: A Rabbit Model", presented at the American Society of Oculoplastic and Reconstructive Surgeons Annual Meeting, Chicago, Illinois, U.S.A. (October 1996)

To verify MEDPOR® porous polyethylene orbital implant, once vascularized, will tolerate a partially exposed titanium screw on the anterior surface of the implant.

A porous polyethylene orbital implant, one vascularized in an animal orbit, may be fitted with a titanium screw (MEDPOR Motility Coupling Post) the exposed head of which can be coupled to an ocular prosthesis for better motility.

Ten New Zealand white rabbits were enucleated and given MEDPOR Porous Polyethylene Orbital Implants (PPOI). Eight weeks postoperatively, MEDPOR Motility Coupling Posts (MCP) were placed into the orbital implants. Clinical tissue tolerance and histological response to the new device were noted.

The titanium screws were well-tolerated by the animals. No case of postoperative infection, conjunctival inflammation, conjunctival erosion, MCP dislocation, or PPOI fragmentation was noted. A fibrous tissue overgrowth over the titanium head was noted in all screws with head height of 2.5 mm. The fibrous tissue overgrowth was not observed in screws with head height of 4.0 mm or higher.

During the 6 month observation period, all implanted MEDPOR Motility Coupling Posts demonstrated favorable tissue tolerance and stable interfaces between the MCP and the conjunctiva and between the MCP and the PPOI.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Choi, J.C. A Video Presentation, "MEDPOR® Motility Coupling Post: A Rabbit Model", presented at the American Society of Oculoplastic and Reconstructive Surgeons Annual Meeting, Chicago, Illinois, U.S.A. (October 1996)

This video desmonstrates Dr. Choi's technique for secondary placement of the MEDPOR® Motility Coupling Post. A copy of this video is available upon request from Porex Surgical.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Rubin, Peter A. D., "Conical Porous Polyethylene Enucleation Implant", Journal of the American Society of Ocularists, 25th Edition (1994)

The use of porous polyethylene as an enucleation orbital implant is discussed in this comprehensive article. The author highlights the porous material's encouragement of fibrovascular tissue ingrowth which anchors the implant, limits its migration and helps to reduce infection. He presents a new polyethylene design which features a posterior conical projection, a superior projection, a ledge that permits direct coupling of the extraocular muscles, a non-spherical shape and the flattening of the implant's anterior surface. The article also includes techniques for preparation and interoperative implantation and suggestions for prosthetic fitting. The author asserts that because preliminary results have been very encouraging, a multicenter clinical trial of this new implant design is currently being undertaken. He believes that porous polyethylene will serve to enhance the appearance and quality of life of those patients who have sustained the loss of an eye.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

Karesh, J.W. and Dresner, S.C. "High Density Porous Polyethylene As A Successful Anophthalmic Socket Implant", Opthalmology, Vol. 101, No. 10 (October 1994)

Twenty-one (21) patients underwent MEDPOR® ocular sphere implantation over a three and a half year period. Follow-up averaged 19 months with a range of 7 to 43 months. None of the implants received a scleral covering. Eleven (11) procedures were performed for primary enucleations and eviscerations, all of which showed excellent postoperative socket motility. Each patient was fitted with a permanent prosthesis four to six weeks following surgery. No infections, extrusions, migrations, or significant inflammation occurred. The authors concluded that MEDPOR is effective for use in the anophthalmic socket, is considerably less expensive than hydroxyapatite and does not require scleral covering for muscle attachment.

This abstract is provided for educational purposes only. It contains information about cleared uses of the product. It may contain other potential uses not cleared by the Food and Drug Administration and not advocated by the manufacturer. The uses and opinions expressed within the article are those of the author derived from his or her personal experience with the product. For additional information on cleared product specific indications and to request a copy of the cleared labeling please contact the manufacturer's customer care department.

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