The posterior auricular muscle complex graft as a porous orbital implant wrap: long-term follow-up over a 31-year period.

PURPOSE: Orbital implant exposures, infections, and extrusions can occur many years following enucleation or evisceration. This study analyzes complication rates following porous orbital implant wrapped with a posterior auricular muscle complex graft (PAMCG). METHODS: This is a retrospective study of patients who underwent orbital implantation following enucleation using this technique between 1992 and 2013. Only cases with a minimum of 18 months of follow-up were included. No patients underwent peg implantation. Patient's demographics, follow-up time, type of implant, complications including wound dehiscence, exposure, postoperative infection, and extrusion were recorded. RESULTS: This study included 36 orbits of 36 patients with a mean age of 39.3 ± 23.2 years (range, 3-84 years). Thirty patients had hydroxyapatite implants and six had porous polyethylene. The average follow-up time was 12.6 ± 5.6 years (range, 1.5-31.0 years). There were no implant extrusions, and only one exposure resulting in orbital infection that necessitated implant removal (2.8%). CONCLUSION: Wrapping porous orbital implants with PAMCG had favorable long-term outcomes over a thirty-one-year period.

Surgical and Ophthalmologic Outcomes of Reconstruction in Patients Treated With Eye-Sparing Surgery and Radiation Therapy for Tumors of the Lacrimal Drainage Apparatus.

INTRODUCTION: Tumors involving the lacrimal drainage apparatus can be effectively treated with oncologic eye-sparing resection, immediate reconstruction, and adjuvant radiation. The extirpative technique is well described, whereas the reconstructive approach and outcomes are limited and largely anecdotal. The present study describes the largest series in the literature evaluating outcomes after reconstruction after globe-preserving oncologic resection. METHODS: A retrospective review was performed for all patients undergoing reconstruction after resection of lacrimal gland tumors from 2008 to 2019. Reconstruction and ophthalmologic outcomes were assessed. RESULTS: Of the 17 patients included, 2 underwent complex repair, 6 were reconstructed with a locoregional flap, and 9 underwent free flap reconstruction. All patients were treated with adjuvant radiation therapy. The median follow-up was 19 months (range, 5-126 months). Defects reconstructed with free flaps had lower rates of wound dehiscence and fistula formation compared with those reconstructed with other techniques (11% vs 25%, P = 0.45). Patients undergoing reconstruction with free tissue transfer also tended to have lower rates of ectropion, keratopathy and decreased visual acuity compared with those undergoing nonmicrosurgical reconstruction (33% vs 50%, P = 0.48; 11% vs 38%, P = 0.20; 56% vs 75%, P = 0.40, respectively). These differences were not statistically significant. CONCLUSIONS: This is the first study to compare reconstructive and functional outcomes of nonmicrosurgical reconstruction and microsurgical free tissue transfer in the setting of eye-sparing surgery for tumors of the lacrimal drainage apparatus. Although various reconstructive options are feasible, microsurgical free tissue transfer is often used at our center and is associated with reliable outcomes.

Prognostic Factors for Orbital Exenteration, Local Recurrence, Metastasis, and Death From Disease in Conjunctival Squamous Cell Carcinoma.

PURPOSE: Information regarding risk of metastasis and disease-related death (DD) from conjunctival squamous cell carcinoma (SCC) is relatively scarce. We explored prognostic factors for orbital exenteration, local recurrence, nodal metastasis, and DD in patients with conjunctival SCC. DESIGN: Retrospective cross-sectional study. METHODS: All consecutive patients with conjunctival SCC treated by the senior author at MD Anderson Cancer Center during1999-2018 were included. Survival curves were estimated using the Kaplan-Meier method, and survival differences were assessed using 2-sided log-rank tests. RESULTS: The study included 44 patients (24 men, 20 women); median age was 64 years (range, 40-90). T categories at presentation were as follows: Tis, 20 patients; T2, 8; T3, 9; and T4, 7. Eighteen patients (41%) had tumors exclusively in the bulbar conjunctiva; 26(59%) had nonbulbar conjunctival involvement. The median follow-up time was 29.2 months (95% CI: 21.8-44.3). Orbital exenteration was performed in 10 cases (23%) and was associated with T3 or more advanced disease at presentation (p < 0.001). Seven patients developed local recurrence during follow up. History of organ transplant correlated with local recurrence and orbital exenteration (p < 0.01). Nodal metastasis was present in 1 patient at presentation and occurred in 3 patients during follow up, for an overall nodal metastasis rate of 9% (4/44). By end of follow up, 2 patients had died of disease, 4 had died of other causes, and 38 were alive with no evidence of disease. The results suggest that both orbital exenteration and nodal metastasis are independent variables associated with DD. CONCLUSIONS: In patients with conjunctival SCC, orbital exenteration and nodal metastasis are associated with DD and organ transplantation is associated with orbital exenteration.

Immune Checkpoint Inhibitor Therapy as an Eye-Preserving Treatment for Locally Advanced Conjunctival Melanoma.

The authors present 2 patients with locally advanced conjunctival melanoma for whom definitive surgery would mean an orbital exenteration with its associated inherent total visual loss and major facial disfigurement. Instead both patients were treated with immune checkpoint inhibitor therapy. In 1 patient neoadjuvant pembrolizumab was used for approximately 12 months and the patient experienced near-total clinical resolution of the conjunctival melanoma. Multiple surgical biopsies of very small residual pigmentation showed pigmented macrophages and a complete pathologic response. In the second patient who presented with a locally advanced and metastatic conjunctival melanoma, significant shrinkage of conjunctival mass was observed after treatment with a combination of ipilimumab and nivolumab for 5 months, and this allowed preservation of the eye and ocular function.

Inverted Papilloma of the Orbit and Nasolacrimal System.

PURPOSE: Periocular inverted papilloma (IP) is a rare, locally aggressive tumor with a propensity for recurrence and malignant transformation. Historically treated via wide excision, this study examines the characteristics and management of periocular IP, comparing those confined to the nasolacrimal system with those invading the orbit. METHODS: An Institutional Review Board-approved, Health Insurance Portability and Accountability Act-compliant retrospective, comparative case series was conducted in patients with IP of the orbit or nasolacrimal system across 15 clinical sites. RESULTS: Of 25 patients, 22 met inclusion criteria with 9 limited to the nasolacrimal system and 13 invading the orbit. Mean age was 60.4 years, 55% were women, all were unilateral. Mean follow-up was 48 months. Rates of smoking, dust and/or aerosol exposure, human papillomavirus (HPV) status, and inflammatory polyps were elevated compared to rates in the general population (45%, 18%, 18%, and 14%, respectively). Bony erosion on computed tomography scans was statistically significantly associated with orbit-invading IP (p = 0.002). Treatment involved all confined IP undergoing surgery alone while 39% of orbit-invading IP also received radiation therapy and/or chemotherapy (p = 0.054). Orbit-invading IP was more likely to be excised with wide margins than IP confined to the nasolacrimal system (85% vs. 22%, p = 0.007). Overall rates of malignancy, recurrence, and patient mortality from IP were found to be 27%, 23%, and 9%, respectively. CONCLUSIONS: IP invading the orbit typically requires aggressive therapy, while IP confined to the nasolacrimal system may be treated more conservatively. Using risk factors, characteristics, and outcomes, a treatment algorithm was created to guide management.

Malignant Mixed Tumor (Carcinoma Ex Pleomorphic Adenoma) of the Lacrimal Gland.

PURPOSE: To review the clinical presentation, treatment, and prognosis of patients with malignant mixed tumor (carcinoma ex pleomorphic adenoma) of the lacrimal gland. METHODS: Clinical records and radiographic images were reviewed for patients with malignant mixed tumor of the lacrimal gland treated at the center during 2008-2019. RESULTS: The study included 9 patients (6 men, 3 women) aged 17-66 years (median age, 56 years). Six had primary malignant mixed tumor with no history of orbital lesions, and 3 had previously been diagnosed with pleomorphic adenoma. Tumor, Node, Metastasis classification per the eighth edition of the American Joint Committee on Cancer (AJCC) Cancer Staging Manual were T1aN0M0 in 2 patients, T2aN0M0 in 3 patients, T4bN0M0 in 2 patients, and T4cN0M0 in 2 patients. Two patients underwent orbital exenteration, 6 patients underwent eye-sparing surgery, and 1 patient had an unresectable tumor because of cavernous sinus extension. All patients received radiotherapy (intensity-modulated radiotherapy in 3 and proton therapy in 6). All patients received chemotherapy, 8 concurrently with radiotherapy and 1 after radiotherapy. The median follow-up time was 70 months. At last contact, 6 patients were alive without evidence of disease; 2 had died of disease, 1 of distant metastasis, and the other of cavernous sinus invasion. CONCLUSIONS: The findings suggest that de novo malignant mixed tumor of the lacrimal gland is more common than disease that results from transformation after incomplete resection of lacrimal gland pleomorphic adenoma. Most cases can be treated with eye-sparing surgery and radiation unless skull base extension is present.

Prognostic Value of the Staging System for Eyelid Tumors in the 7th Edition of the American Joint Committee on Cancer Staging Manual.

PURPOSE: To determine the prognostic value of the staging criteria for eyelid tumors in the 7th edition of the American Joint Committee on Cancer (AJCC) staging manual and to determine, for each type of eyelid tumor, which AJCC T categories are associated with increased risk of nodal metastasis and thus potential usefulness of sentinel lymph node biopsy. METHODS: Systematic review and analysis of articles found by searching PubMed and Google Scholar using the search terms "AJCC," "eyelid," "carcinoma," and "melanoma." RESULTS: Rates of local recurrence, regional nodal metastasis, and distant metastasis were approximately 7% to 10%, 1% to 9%, and 0% to 0.8%, respectively, for eyelid squamous cell carcinoma; 5% to 6%, 8% to 23%, and 2% and 14%, respectively, for eyelid sebaceous carcinoma; 10%, 10% to 22%, and 19% to 22%, respectively, for eyelid Merkel cell carcinoma (when staged according to the criteria for eyelid carcinoma as opposed to Merkel cell carcinoma), 14%, 5%, and 0%, respectively, for eyelid sweat gland carcinoma; and 2%, 9%, and 6%, respectively, for eyelid melanoma. Overall, the risks of local recurrence and regional nodal and distant metastasis appeared to increase with increasing AJCC T category, although not statistically significant in all studies. Clinical T2b or greater T category was significantly associated with increased risk of nodal metastasis for eyelid squamous cell carcinomas, sebaceous carcinomas, Merkel cell carcinomas (staged with eyelid carcinoma criteria), sweat gland carcinomas, and melanomas. Clinical T3 or greater T category was significantly associated with distant metastasis for eyelid carcinomas and melanomas. CONCLUSION: For eyelid carcinomas and eyelid melanomas, AJCC 7th edition T category correlates with the risks of nodal and distant metastasis, with T2b and larger tumors associated with highest risk of nodal metastasis. Patients with T2b or larger tumors may be candidates for sentinel lymph node biopsy or close nodal surveillance.

Immune Checkpoint Inhibitors for Treatment of Metastatic Melanoma of the Orbit and Ocular Adnexa.

Programmed cell death 1 (PD-1) inhibitors are members of a new class of drugs known as immune checkpoint inhibitors and have proven efficacy in the treatment of metastatic melanoma. Herein, the authors report the use of nivolumab and pembrolizumab, 2 recently Food and Drug Administration-approved PD-1 inhibitors, in 3 patients: 1 with metastatic conjunctival melanoma and 2 with metastatic cutaneous melanoma and orbital involvement. The patients' metastatic disease responded well to drug treatment. As of this writing, 2 patients have completed therapy and remain disease free at least 1 year after treatment completion; the other patient is still receiving treatment, and his orbital disease is responding. The authors herein describe the use of PD-1 inhibitors as a new alternative in the treatment of metastatic melanoma to the orbit or metastatic ocular adnexal melanomas in these clinical settings.

Thymic Origin Neuroendocrine Carcinoma Metastasizing to the Orbit in an Otherwise Asymptomatic Patient.

A 39-year-old man without a significant medical history developed headaches, OS swelling, and limited left-sided ocular motility. An ultrasound of the left orbit and head MRI revealed a retro-orbital mass. A partial left anterior orbitotomy with partial resection was performed, and histopathologic examination of the resected tumor portion was suggestive of a neuroendocrine carcinoma. A large, anterior mediastinal mass was found on chest imaging, and the patient was diagnosed with a primary thymic neuroendocrine tumor. To the authors' knowledge, this is the first report of an otherwise healthy patient presenting with the mass effects of a thymic neuroendocrine carcinoma metastasis to the orbital tissues before detection of the primary thymic malignancy.

Frequency and Clinical Course of Residual Orbital Masses After Treatment of Orbital Rhabdomyosarcoma.

PURPOSE: To evaluate the frequency and clinical course of residual orbital masses on imaging studies after multimodality treatment for orbital rhabdomyosarcoma. DESIGN: Retrospective case series. METHODS: We reviewed records of patients with primary orbital rhabdomyosarcoma who underwent chemotherapy and radiotherapy after surgical biopsy or debulking at 4 US centers during 1998-2019. Demographics, histologic subtype, tumor response 12 weeks after chemotherapy initiation and after completion of all treatment, and imaging findings were analyzed. RESULTS: Thirty-two patients met inclusion criteria. Twenty-two were male, and 30 were younger than 18 years. Histologic subtype was embryonal in 22 patients, alveolar in 8, and mixed embryonal/alveolar in 2. Median follow-up time was 46 months (range, 4.9-199 months). Two patients died. Twenty-seven patients had reliable end-of-treatment imaging findings, of whom 9 had a residual mass. Three residual masses disappeared spontaneously (by 4, 32, and 53 months), 2 remained at last contact, at 2 and 7 years of follow-up, and 3 were excised; 1 progressed and underwent an exenteration. Complete response at 12 weeks was associated with complete response at the end of treatment (P < .001). Patients with T1 or T2 tumor at presentation were more likely to have complete response at last contact than were those with T3 or T4 tumor (P < .05). Biopsy type (incisional or excisional) was not associated with response to treatment at any time point. CONCLUSION: A residual orbital mass on imaging may be present after multimodality treatment in approximately one-third of patients. Resolution without biopsy or excision varied from months to years.

Unusual cause of acute sinusitis and orbital abscess in COVID-19 positive patient: Case report.

BACKGROUND: Peptoniphilus indolicus is not usually seen in the eye or paranasal sinuses but is a commensal of the human vagina and gut. However, with COVID-19, eye infections and other unusual complications are possible with such unsuspected bacteria. CASE PRESENTATION: The patient is a 76-year-old white male from a nursing home tested positive for COVID-19 and was sent from a nursing facility for left eye drainage and psychiatric evaluation. Upon presentation, the patient was not fully oriented and could not provide a history of the eye drainage. CT scan showed sinusitis with left orbital and periorbital abscess formation, cellulitis, and extensive osteomyelitis. He underwent endoscopic transnasal drainage and orbiotomy. Cultures returned positive for methicillin-resistant Stapholococcus aureus (MRSA), Streptococcus constellatus, and Peptoniphilus indolicus. He was maintained on several days of IV antibiotics and returned to the nursing home. He then presented 2 months later and required enucleation of his globe, due to the presence of multiple scleral perforations in the setting of orbital abscess, as well as removal of necrotic orbital bone. CONCLUSIONS: Given the concomitant infection with COVID-19 and unusual presentation, the patient's sinus cultures support the notion that COVID-19 can affect the presence of bacteria within certain anatomical regions. Specifically, Peptoniphilus indolicus is not normally found outside of the vagina or gut biome. Avascular, pale mucosa and bone of the nasal cavity was noted during surgery of this COVID-19 infected patient, which is in contrast to the friable and edematous tissue typically found in acutely infected sinuses. Our patient's orbital abscess began to drain spontaneously through the skin, which is rare for orbital abscesses. Also uncommon with orbital abscesses is the need for enucleation, which in this case was deemed necessary given that the abscess had perforated the sclera in multiple locations.

Prognostic factors for local recurrence and survival and impact of local treatments on survival in lacrimal gland carcinoma.

BACKGROUND/AIMS: To identify prognostic factors for local recurrence, distant metastasis and disease-specific survival (DSS) for lacrimal gland carcinoma. METHODS: All consecutive patients with lacrimal gland carcinoma treated from January 1998 through December 2018 were included. Log-rank tests and univariate Cox proportional hazards regression models were used to study risk factors and survival. RESULTS: Overall, 55 patients were included in this study, and 5 patients were excluded from the survival analysis. Median age was 46 years (range: 10-76). 43 patients (78%) had adenoid cystic carcinoma (ACC). 31 patients (56%) had T2 disease at presentation. 28 patients (51%) underwent orbital exenteration with or without adjuvant radiotherapy or chemoradiation, 26 (47%) underwent eye-sparing surgery with or without adjuvant radiotherapy or chemoradiation, and 1 received palliative chemoradiation. 11 patients (22%) experienced local recurrence; 14 (29%) experienced distant metastasis. Five- and 10-year local-recurrence-free survival rates were 0.71 (95% CI 0.58 to 0.88), and 5- and 10-year distant-metastasis-free survival rates were 0.67 (95% CI 0.53 to 0.85) and 0.49 (95% CI 0.30 to 0.81), respectively. There was no significant difference in risks of local recurrence, distant metastasis or DSS between ACC patients who had orbital exenteration and those who had eye-sparing surgery. Perineural invasion was negatively associated with local-recurrence-free survival (p=0.02). Among patients with ACC, basaloid/solid histologic type was associated with significantly worse DSS than non-basaloid/solid histologic type (p<0.01). CONCLUSIONS: For lacrimal gland carcinoma, orbital exenteration with adjuvant therapy and eye-sparing surgery with adjuvant therapy are associated with similar recurrence outcomes. Eye-sparing surgery is associated with better DSS. Perineural invasion is a risk factor for local recurrence. ACC with basaloid/solid subtype correlates with worse DSS.

Immunotherapy With Programmed Cell Death 1 Inhibitors for 5 Patients With Conjunctival Melanoma.

Importance: Conjunctival melanoma has the potential for regional lymphatic and distant metastasis. There is an urgent need for effective treatment for patients with metastatic or locally advanced conjunctival melanoma. Objective: To describe the use of immune checkpoint inhibitors for the treatment of conjunctival melanoma in 5 adult patients. Design, Setting, and Participants: A retrospective review was conducted of the medical records of 5 patients with conjunctival melanoma who were treated with immune checkpoint inhibitors from March 6, 2013, to July 7, 2017. Main Outcomes and Measures: Response to treatment and disease-free survival. Results: Of the 5 patients (4 women and 1 man) with metastatic conjunctival melanoma, 4 were treated with a programmed cell death 1 (PD-1) inhibitor, nivolumab, and had a complete response to treatment with no evidence of disease at 1, 7, 9, and 36 months after completing treatment. One patient with metastatic conjunctival melanoma was treated with another PD-1 inhibitor, pembrolizumab, and had stable metastases during the first 6 months of treatment. Later disease progression resulted in treatment cessation after 11 months and switching to another therapy. Two patients treated with nivolumab developed autoimmune colitis that necessitated stopping the immunotherapy; these patients subsequently were managed with systemic corticosteroids or infliximab. Conclusions and Relevance: This case series report suggests that anti-PD-1 therapy can be used to treat metastatic conjunctival melanoma. Longer follow-up is needed to determine the long-term disease-free survival. Future studies might assess the potential for immune checkpoint inhibitors to obviate the need for orbital exenteration in selected patients with locally advanced disease.

Congenital complex corneal choristoma associated with unilateral bony calvarial defects, subcutaneous nodules, and alopecia.

Complex corneal choristoma is a rare finding and its relationship with systemic disease is poorly understood. We present a 3-day-old boy with the constellation of left-sided congenital complex corneal choristoma, limbal dermoid, ipsilateral bony skull defects, and bilateral subcutaneous vascularized nodules with overlying alopecia and scalp nevi. To our knowledge this is the first case of complex choristoma involving the presence of associated bony calvarial defects. This presentation may contribute to a greater understanding of the systemic findings associated with the condition. Furthermore, it may shed light on the possible syndromic spectrum associated with complex choristoma and its underlying pathophysiology.

Evaluation of uveal and capsule biocompatibility of a single-piece hydrophobic acrylic intraocular lens with ultraviolet-ozone treatment on the posterior surface.

PURPOSE: To evaluate a single-piece hydrophobic acrylic intraocular lens (IOL) with ultraviolet-ozone (UV-O3) treatment on the posterior surface and compare it with an identical untreated IOL in a rabbit model. SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA. DESIGN: Experimental study. METHODS: Study IOLs were implanted in the right eyes and control IOLs in the left eyes of 10 New Zealand rabbits. Slitlamp examinations were performed 1 to 6 weeks postoperatively. Neodymium:YAG (Nd:YAG) posterior capsulotomy was performed in both eyes of 5 rabbits after the 4-week slitlamp examination. At 6 weeks, the rabbits were killed humanely and their globes were enucleated. Capsular bag opacification was scored from the posterior aspect (Miyake-Apple view), and the eyes were processed for histopathology. RESULTS: At 4 weeks, the mean posterior capsule opacification (PCO) scores were 0.88 ± 0.33 (SD) in the study eyes and 2.55 ± 1.13 in the control eyes (P=.003, 2-tailed paired t test). Performance of Nd:YAG posterior capsulotomy was similar in both groups. Gross postmortem examination also showed statistically less peripheral PCO in eyes with the study IOLs than in control eyes. There was no difference in histopathologic findings between study eyes and control eyes and no signs of untoward inflammation or toxicity in any eye evaluated. CONCLUSIONS: Treatment of the posterior surface of a single-piece hydrophobic acrylic IOL with UV-O3 appears to prevent PCO, likely by increasing adhesion between the posterior capsule and the IOL while retaining uveal biocompatibility. Performance of Nd:YAG posterior capsulotomy was similar between treated IOLs and untreated IOLs.

Adjustable intraocular lens power technology.

UNLABELLED: We present an overview of the adjustable intraocular lens (IOL) technologies that are available or under development. This includes IOL technologies that can be adjusted using secondary surgical procedures, such as the multicomponent IOL, the mechanically adjustable IOL, and the repeatedly adjustable IOL; IOLs that can be adjusted noninvasively in the postoperative setting, such as the magnetically adjustable IOL, the liquid crystal IOLs with wireless control; and IOLs that can be adjusted using the femtosecond laser or 2-photon chemistry. Finally, we discuss the preclinical and clinical studies of the light-adjustable intraocular lens (LAL) that is available commercially in Europe and Mexico and in the final stages of clinical evaluation in the United States. The general principles of each technology, as well as their research status, are described. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Spontaneous bilateral anterior partial in-the-bag intraocular lens dislocation following routine annual eye examination.

UNLABELLED: We present the case of an 81-year-old man with pseudoexfoliation syndrome (PXF) in whom spontaneous bilateral anterior partial in-the-bag intraocular lens (IOL) dislocation was diagnosed following a routine dilated examination that demonstrated only mild pseudophacodonesis with no evidence of subluxation. Uneventful cataract surgery with placement of single-piece hydrophobic acrylic posterior chamber IOLs had been performed in both eyes 7 years previously. Bilateral IOL repositioning with scleral fixation was performed to correct the dislocation. Postoperative examinations showed remarkable improvement in visual acuity and IOL stability. We hypothesize that zonular weakness secondary to PXF predisposed the patient to bilateral IOL partial dislocation. Pupil dilation in the setting of mild pseudophacodonesis at the time of routine examination may have been a precipitating factor. To our knowledge, bilateral IOL subluxation/dislocation has been described in a limited number of case reports. FINANCIAL DISCLOSURE: No author has a financial or proprietary interest in any material or method mentioned.

Long-term uveal and capsular biocompatibility of a new accommodating intraocular lens.

PURPOSE: To evaluate long-term uveal and capsular biocompatibility of a new accommodating intraocular lens (IOL). SETTING: John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA. DESIGN: Experimental study. METHODS: Bilateral phacoemulsification was performed in 14 rabbits; 1 eye received the accommodating IOL (Fluidvision) and the other received a hydrophobic acrylic control IOL. Slitlamp examinations were performed at postoperative weeks 1 to 4 and months 2, 3, 4, and 6. Six rabbits were humanely killed at 2 months and 8 rabbits at 6 months. After gross examination with the Miyake-Apple view, selected IOLs were removed for implant cytology. All globes were then sectioned and processed for histopathologic examination. RESULTS: Uveal biocompatibility of study and control IOLs was similar in clinical and pathologic examinations up to 6 months postoperatively. In the study group, anterior capsule opacification appeared absent and posterior capsule opacification (PCO) was significantly less than in the control group. At the gross examination at 6 months, central PCO was 0.8 ± 0.5 (SD) in the study IOLs and 3.7 ± 0.4 in the control IOLs (P < .0001, 2-tailed paired t test). Histopathologic examination confirmed the relative lack of capsule opacification in study eyes compared with controls and the absence of untoward inflammatory reaction or toxicity in all eyes. CONCLUSIONS: The accommodating IOL maintained an expanded capsular bag secondary to the large size of the haptic elements without significant contact with the anterior capsule. This appeared to prevent overall capsular bag opacification and to retain uveal and capsular biocompatibility.