A Comparison of Sequential Glaucoma Drainage Device Implantation Versus Cyclophotocoagulation Following Failure of a Primary Drainage Device.

PURPOSE: To compare sequential glaucoma drainage device (GDD) implantation with transscleral diode cyclophotocoagulation (CPC) following failure of a primary GDD. MATERIALS AND METHODS: A retrospective review of all patients who underwent GDD implantation at a single institution over 10 years. Patients who required an additional GDD and/or CPC were analyzed. Success was defined as absence of loss of light perception, reoperation for glaucoma, and intraocular pressure (IOP) >21 or <6 at 2 consecutive visits after an initial 3-month period. RESULTS: Thirty-two patients received sequential GDD. Twenty-one underwent CPC. Cohorts were statistically similar in regards to age, sex, race, and number of previous surgeries. Preoperatively, the GDD cohort had a lower IOP and better visual acuity. The mean length of follow-up was 37.9 months for the GDD group and 46.3 months for CPC. Both procedures significantly reduced IOP; however, CPC led to a greater reduction (P=0.0172). Survival analysis found the 5-year probability of surgical success to be 65.3% for sequential GDD and 58.0% for CPC (P=0.8678). No cases of phthisis occurred in either group. There were 2 cases of endophthalmitis (6.3%) in the GDD group, and none in the CPC group. In eyes without preexisting corneal edema, estimated corneal decompensation probability at 3 years was 31.6% for GDD and 6.7% for CPC (P=0.0828). CONCLUSIONS: Sequential GDD and CPC are both effective at reducing IOP following the failure of a primary GDD. CPC after GDD failure warrants further investigation as it led to a greater reduction in IOP with fewer serious adverse events.

Glaucoma drainage devices: risk of exposure and infection.

PURPOSE: To identify risk factors for device exposure and intraocular infection following implantation of a glaucoma drainage device. DESIGN: Retrospective case series. METHODS: The medical records of adult patients undergoing glaucoma drainage device implantation at an academic medical center between 2000 and 2010 were reviewed. Main outcome measures included device exposure and intraocular infection. RESULTS: Seven hundred and sixty-three cases were identified. These included 702 primary implants (ie, the first drainage device implanted into an eye) and 61 sequential implants. Among 702 primary implants, there were 41 cases of exposure (5.8%). None of the potential risk factors were statistically significant. Implant location was found to be a marginally significant risk factor. The exposure rates for inferior and superior implants were 12.8% (5 of 39) and 5.4% (36 of 663), respectively (P = .056). The highest rate of exposure for primary implants occurred in the inferior-nasal quadrant (17.2%, 5 of 29). The rate of exposure for sequential devices was 13.1% (8 of 61), with the highest rate also found in the inferior-nasal quadrant (20%, 5 of 25). Of 49 total exposures, 8 were associated with intraocular infection (16.3%). Exposures over inferior implants were more likely to be associated with infection than exposures over superior implants (41.7% vs 8.1%; P = .0151). CONCLUSION: Implant location approached, but did not reach, statistical significance as a risk factor for exposure. Exposures over inferior implants place patients at a higher risk of infection than superior exposures. More studies are needed to identify modifiable risk factors for device exposure.

Melatonin supplementation to treat the metabolic syndrome: a randomized controlled trial.

BACKGROUND: Supplemental melatonin may ameliorate metabolic syndrome (MetS) components, but data from placebo-controlled trials are lacking. METHODS: We conducted a double-blind, placebo-controlled, crossover, Phase II randomized pilot clinical trial to estimate the effects of melatonin supplementation on MetS components and the overall prevalence of MetS. We randomized 39 subjects with MetS to receive 8.0 mg oral melatonin or matching placebo nightly for 10 weeks. After a 6-week washout, subjects received the other treatment for 10 more weeks. We measured waist circumference, triglycerides, HDL cholesterol, fasting glucose, and blood pressure (BP) in each subject at the beginning and end of both 10-week treatment periods. The primary outcome was the mean 10-week change in each MetS component, and a secondary outcome was the proportion of subjects free from MetS, after melatonin versus placebo. RESULTS: The mean 10-week change for most MetS components favored melatonin over placebo (except fasting glucose): waist circumference -0.9 vs. +1.0 cm (p = 0.15); triglycerides -66.3 vs. -4.2 mg/dL (p = 0.17); HDL cholesterol -0.2 vs. -1.1 mg/dL (p = 0.59); fasting glucose +0.3 vs. -3.1 mg/dL (p = 0.29); systolic BP -2.7 vs. +4.7 mmHg (p = 0.013); and diastolic BP -1.1 vs. +1.1 mmHg (p = 0.24). Freedom from MetS tended to be more common following melatonin versus placebo treatment (after the first 10 weeks, 35.3% vs. 15.0%, p = 0.25; after the second 10 weeks, 45.0% vs. 23.5%, p = 0.30). Melatonin was well-tolerated. CONCLUSIONS: Melatonin supplementation modestly improved most individual MetS components compared with placebo, and tended to increase the proportion of subjects free from MetS after treatment. TRIAL REGISTRATION: NCT01038921, clinicaltrials.gov.

Long-term risk of glaucoma after congenital cataract surgery.

PURPOSE: To report the long-term risk of glaucoma development in children following congenital cataract surgery. DESIGN: Retrospective interventional consecutive case series. METHODS: We retrospectively reviewed the records of 62 eyes of 37 children who underwent congenital cataract surgery when <7 months of age by the same surgeon using a limbal approach. The Kaplan-Meier method was used to calculate the probability of an eye's developing glaucoma and/or becoming a glaucoma suspect over time. RESULTS: The median age of surgery was 2.0 months and the median follow-up after cataract surgery was 7.9 years (range, 3.2-23.5 years). Nine eyes (14.5%) developed glaucoma a median of 4.3 months after cataract surgery and an additional 16 eyes (25.8%) were diagnosed as glaucoma suspects a median of 8.0 years after cataract surgery. The probability of an eye's developing glaucoma was estimated to be 19.5% (95% CI: 10.0%-36.1%) by 10 years after congenital cataract surgery. When the probability of glaucoma and glaucoma suspect were combined, the risk increased to 63.0% (95% CI: 43.6%-82.3%). CONCLUSIONS: Long-term monitoring of eyes after congenital cataract surgery is important because we estimate that nearly two thirds of these eyes will develop glaucoma or become glaucoma suspects by 10 years after cataract surgery.

Validation data-based adjustments for outcome misclassification in logistic regression: an illustration.

Misclassification of binary outcome variables is a known source of potentially serious bias when estimating adjusted odds ratios. Although researchers have described frequentist and Bayesian methods for dealing with the problem, these methods have seldom fully bridged the gap between statistical research and epidemiologic practice. In particular, there have been few real-world applications of readily grasped and computationally accessible methods that make direct use of internal validation data to adjust for differential outcome misclassification in logistic regression. In this paper, we illustrate likelihood-based methods for this purpose that can be implemented using standard statistical software. Using main study and internal validation data from the HIV Epidemiology Research Study, we demonstrate how misclassification rates can depend on the values of subject-specific covariates, and we illustrate the importance of accounting for this dependence. Simulation studies confirm the effectiveness of the maximum likelihood approach. We emphasize clear exposition of the likelihood function itself, to permit the reader to easily assimilate appended computer code that facilitates sensitivity analyses as well as the efficient handling of main/external and main/internal validation-study data. These methods are readily applicable under random cross-sectional sampling, and we discuss the extent to which the main/internal analysis remains appropriate under outcome-dependent (case-control) sampling.