The Primary Tube Versus Trabeculectomy Study: Methodology of a Multicenter Randomized Clinical Trial Comparing Tube Shunt Surgery and Trabeculectomy with Mitomycin C.

PURPOSE: To describe the methodology of the Primary Tube Versus Trabeculectomy (PTVT) Study. DESIGN: Multicenter randomized clinical trial. PARTICIPANTS: Patients with medically uncontrolled glaucoma and no prior incisional ocular surgery. METHODS: Patients are being enrolled at 16 clinical centers and randomly assigned to treatment with a tube shunt (350-mm2 Baerveldt glaucoma implant) or trabeculectomy with mitomycin C (0.4 mg/ml for 2 minutes). MAIN OUTCOME MEASURES: The primary outcome measure is the rate of surgical failure, defined as intraocular pressure (IOP) more than 21 mmHg or reduced by less than 20% from baseline, IOP of 5 mmHg or less, reoperation for glaucoma, or loss of light perception vision. Secondary outcome measures include IOP, glaucoma medical therapy, visual acuity, visual fields, and surgical complications. CONCLUSIONS: Practice patterns vary in the surgical management of glaucoma, and opinions differ among surgeons regarding the preferred primary operation for glaucoma. The PTVT Study will provide valuable information comparing the 2 most commonly performed glaucoma surgical procedures.

A multicenter analysis of the ophthalmic knowledge assessment program and American Board of Ophthalmology written qualifying examination performance.

OBJECTIVE: To compare the performance on the American Board of Ophthalmology Written Qualifying Examination (WQE) with the performance on step 1 of the United States Medical Licensing Examination (USMLE) and the Ophthalmic Knowledge Assessment Program (OKAP) examination for residents in multiple residency programs. DESIGN: Comparative case series. PARTICIPANTS: Fifteen residency programs with 339 total residents participated in this study. The data were extracted from the 5-year American Board of Ophthalmology report to each participating program in 2009 and included residency graduating classes from 2003 through 2007. Residents were included if data were available for the USMLE, OKAP examination in ophthalmology years 1 through 3, and the WQE score. Residents were excluded if one or more of the test scores were not available. METHODS: Two-sample t tests, logistic regression analysis, and receiver operating characteristic (ROC) curves were used to examine the association of the various tests (USMLE, OKAP examination year 1, OKAP examination year 2, OKAP examination year 3, and maximum OKAP examination score) as a predictor for a passing or failing grade on the WQE. MAIN OUTCOME MEASURES: The primary outcome measure of this study was first time pass rate for the WQE. RESULTS: Using ROC analysis, the OKAP examination taken at the third year of ophthalmology residency best predicted performance on the WQE. For the OKAP examination taken during the third year of residency, the probability of passing the WQE was at least 80% for a score of 35 or higher and at least 95% for a score of 72 or higher. CONCLUSIONS: The OKAP examination, especially in the third year of residency, can be useful to residents to predict the likelihood of success on the high-stakes WQE examination.

Outcome of angle surgery in children with aphakic glaucoma.

PURPOSE: To investigate the outcome of trabeculotomy and/or goniotomy for pediatric aphakic glaucoma. METHODS: Retrospective chart review of consecutive children who had congenital cataract surgery between 1990 and 2006 and required goniotomy and/or trabeculotomy for aphakic glaucoma. Treatment success was defined as postoperative intraocular pressure of

Uveitis-glaucoma-hyphema syndrome and corneal decompensation in association with cosmetic iris implants.

PURPOSE: To report a case and management of uveitis-glaucoma-hyphema (UGH) syndrome and corneal decompensation associated with cosmetic iris implants. DESIGN: Interventional case report. SETTINGS: Department of Ophthalmology, University of Minnesota School of Medicine. PATIENTS: A 29-year-old man presented with bilateral redness, severe pain, photophobia, and reduction in visual acuity. Examination revealed intraocular pressure (IOP) of 38 mm Hg and 40 mm Hg right and left eye respectively, bilateral conjunctival injection 3+, epithelial corneal edema, microhyphema, cells 3+ to 4+ and flare 2+, bilateral cosmetic iris implants, and surgical peripheral iridectomies. The patient was diagnosed with UGH syndrome and corneal decompensation associated with cosmetic iris implants. INTERVENTION: Immediate medical management of inflammation and elevated IOP, anterior segment imaging, specular microscopy, Humphrey 24-2 visual field (VF) testing; following failed conservative management, combined trabeculectomy and removal of the iris implants. MAIN OUTCOME MEASURES: Anterior chamber inflammation and microhyphema, IOP, and corneal edema. RESULTS: Anterior segment imaging demonstrated bilateral implant-iris apposition and implant-angle structures apposition. Specular microscopy demonstrated a significant reduction of the number of endothelial cells. VF test demonstrated a right superior arcuate scotoma and a normal left VF. Following surgical treatment IOP normalized and inflammation and microhyphema subsided. However, mild corneal edema persisted. CONCLUSION: Cosmetic iris implantation may lead to UGH syndrome and corneal decompensation. Therefore, its use should be reserved for patients with significant medical indications, and avoided in patients with intact natural iridies, until more short-term and long-term safety data are available.

The natural history of glaucoma and ocular hypertension after pediatric cataract surgery.

INTRODUCTION: We sought to define the prevalence and natural history of ocular hypertension and glaucoma for at least a 10-year period after pediatric cataract surgery. METHODS: We conducted a prospective observational study of patients who received pediatric cataract surgery. Inclusion criteria included 2 directed ophthalmologic examinations performed at a minimum of 5 and 10 years after surgery. RESULTS: A total of 63 patients (22 with bilateral cataracts and 41 with unilateral cataracts) were examined at a median of 15.1 year (range, 10.3-21.3 years) after surgery. A majority of the subjects had glaucoma or ocular hypertension (ie, 59%; 37/63). Nineteen percent (12/63) had glaucoma (5/22 with bilateral cataracts and 7/41 with unilateral cataracts). Approximately half (7/12) had developed glaucoma during the first 5-year observational period and the remainder (5/12) developed it during the following observational period. Forty percent (25/63) of the patients had ocular hypertension in at least one aphakic eye (9/23 with bilateral cataracts and 16/40 with unilateral cataracts). The rate of progression from ocular hypertension to glaucoma over a mean observational period of 7.2 years (range, 6.2-8.1 years) was 23% (5/22). DISCUSSION: Patients who receive surgery for pediatric cataracts are at very high risk of developing ocular hypertension and glaucoma. Patients can develop late-onset glaucoma and ocular hypertension more than 10 years after surgery. Years of ocular hypertension may precede the diagnosis of late-onset glaucoma.

Perioperative complications of trabeculectomy in the collaborative initial glaucoma treatment study (CIGTS).

PURPOSE: To describe the incidence of, and risk factors for, surgical complications reported during and within the first post-operative month after trabeculectomy in the Collaborative Initial Glaucoma Treatment Study (CIGTS). DESIGN: Review of prospectively collected data from a multicenter, randomized clinical trial. METHODS: Complications were tabulated for the 300 CIGTS patients randomized to surgery. Logistic regression analyses were used to identify risk factors for complications. RESULTS: Among the 300 patients randomized to initial surgery, 465 trabeculectomies were performed. Intraoperative complications were reported in 55 eyes (12%). The most frequent reported complications were anterior chamber bleeding during surgery (37 eyes, 8%) and conjunctival buttonhole (five eyes, 1%). Early post-operative complications were reported in 232 eyes (50%). Complications with a frequency over 10% included shallow or flat anterior chamber (62 eyes, 13%), encapsulated bleb (56 eyes, 12%), ptosis (55 eyes, 12%), serous choroidal detachment (52 eyes, 11%), and anterior chamber bleeding or hyphema (48 eyes, 10%). There were three localized suprachoroidal hemorrhages (0.7%) and no cases of endophthalmitis. Older patients were more likely to experience serous choroidal detachment, new anterior or posterior synechiae, and wound leak. Blacks were less likely to experience anterior chamber bleeding, but more likely to experience post-operative ptosis. The number of subjects experiencing bilateral complications was higher than that which would have been predicted by chance alone. CONCLUSIONS: The incidence of transient and self-limiting complications was high in the perioperative period, but we observed few complications with the potential to cause severe sustained vision loss in this group of previously untreated eyes.

Glaucoma following cataract surgery in children: surgically modifiable risk factors.

PURPOSE: To determine the incidence of glaucoma following cataract surgery in children and to identify surgically modifiable risk factors that may influence the development of glaucoma in these eyes. METHODS: All lensectomies performed in patients 18 years old or younger over a 7-year period (1995 through 2001) were identified by conducting a database search. A retrospective chart review was performed for every patient identified. Data extraction included patient's age at surgery, intraocular lens implantation at cataract extraction, date of glaucoma onset, and length of follow-up. Statistical methods included risk ratio calculations and Kaplan-Meier analyses for the "time to glaucoma" for eyes undergoing lensectomy. RESULTS: We identified 116 eyes of 79 children in whom lensectomy was performed. The median age at cataract surgery was 178 days (approval 6 months). Mean follow-up time was 2.7 years. The overall incidence of glaucoma was 11%. Kaplan-Meier analysis demonstrated that eyes operated on at less than 30 days of age were statistically more likely to develop glaucoma than eyes operated on at age 30 days or older (P < .001). For those operated on at less than 30 days of age, the risk ratio was 11.8 for subsequent glaucoma development compared with those operated on at 30 days of age or older. Forty-nine eyes (42%) had primary intraocular lens implantation, and none of these developed glaucoma (P = .001). CONCLUSIONS: Timing of surgery at less than 30 days of age and lack of implantation of an intraocular lens at lensectomy were both associated with an increased risk of subsequent glaucoma. Knowledge of modifiable risk factors is essential to allow ophthalmic surgeons to make cogent decisions regarding the care of children with cataracts.