The association of smoking and alcohol use with age-related macular degeneration in the oldest old: the Study of Osteoporotic Fractures.

PURPOSE: To estimate the incidence of age-related macular degeneration (AMD) and the association of smoking and alcohol in a population of older women. DESIGN: Prospective cohort study. METHODS: Subjects were women who attended the Study of Osteoporotic Fractures year-10 and year-15 follow-up clinic visits and had fundus photographs taken at both visits (n = 1958; 245 Black and 1713 White subjects; mean age at year 10 visit, 78.2 years). Forty-five degree stereoscopic fundus photographs were graded for AMD. Logistic regression was used to test whether risk factors were associated with incident AMD. RESULTS: The overall 5-year AMD incidence was 24.1% (95% confidence interval [CI], 21.7 to 26.6) for early and 5.7% (95% CI, 4.6 to 6.8) for late. Early AMD incidence in White subjects ranged from 21.9% in those aged 74 to 79 years to 33.2% in those 80 to 84 years, but was observed at the slightly lower rate of 29.0% in subjects > or =85 years (trend P < .0001). After confounder adjustment, alcohol consumption was significantly associated with an elevated risk of incident early AMD (odds ratio [OR], 1.57; 95% CI, 1.18 to 2.11). There was an increased risk of early AMD among subjects aged 80 years or older who were smoking compared to those younger than 80 years who were not smoking (OR, 5.49; 95% CI, 1.57 to 19.20; P for interaction = .026). CONCLUSIONS: The magnitude of the greater-than-additive effect of smoking on the age-adjusted risk of AMD reinforces recommendations to quit smoking even for older individuals.

Long-term safety and efficacy of repositioning dislocated plate haptic intraocular lenses in the ciliary sulcus.

PURPOSE: To report safety and efficacy outcomes of repositioning posterior dislocated plate haptic lenses (PHLs) in the ciliary sulcus (CS). DESIGN: Retrospective interventional case series. METHODS: Fifteen consecutive eyes with dislocated PHL repositioned in the CS were reviewed retrospectively. Pars plana vitrectomy was required in 12 of 15 cases. The main outcome variables were initial and final best-corrected visual acuity (BCVA) and length of follow-up. RESULTS: All lenses remained centered for an average of 48.7 months (range 4 to 99 months) of follow-up with no recurrent dislocation, cystoid macular edema, chronic iritis, or iris chaffing. Initial and final BCVA of 20/40 or better was attained in 93.3% (14 of 15) and 66.7% (10 of 15) of eyes, respectively. Decline of final BCVA was attributable to secondary eye diseases and not related to repositioning. CONCLUSIONS: Our study reports dislocated PHL may be managed safely and effectively by placement in the CS with long-term stability under certain clinical scenarios.

Safety results of two phase III trials of an intravitreous injection of highly purified ovine hyaluronidase (Vitrase) for the management of vitreous hemorrhage.

PURPOSE: To evaluate the safety of intravitreous ovine hyaluronidase for the management of vitreous hemorrhage. DESIGN: Two prospective, randomized, placebo-controlled, double-masked studies. Pooled efficacy data are presented in a companion article in this issue of The Journal. METHODS: Subjects with vitreous hemorrhage > or = 1 month, severe at entry and best corrected visual acuity (BCVA) worse than 20/200 in the study eye were randomized to 7.5 IU, 55 IU, 75 IU ovine hyaluronidase, saline, or no injection. Assessments occurred on day 1, week 1, months 1, 2, 3, 6, and then every 6 months for as long as 32 months. Assessments included history, ocular symptoms, adverse events, BCVA, intraocular pressure, external eye examination, slit-lamp biomicroscopy, fundus examination, B-scan ultrasonography, and fundus photography. RESULTS: Of 1362 subjects in the safety population, 1344 received hyaluronidase or saline and 18 no treatment. Iritis was the most common ocular adverse event, occurring in 33.3%, 62.1%, 58.9%, and 62.1% of saline, 7.5 IU, 55 IU, and 75 IU-treated subjects. In eyes with more than mild iritis, a dose response was observed: 8.9%, 20.2%, 33.7%, and 39.7% of saline, 7.5 IU, 55 IU, and 75 IU-treated subjects, respectively, were noted to have moderate or severe iritis. Retinal detachments (RDs) were reported in 9.5% of study eyes: 26 (6.9%), 22 (11.1%), 35 (9.3%), and 45 (11.5%) in the saline, 7.5 IU, 55 IU, and 75 IU-treated subjects. Overall, 1.8% of study eyes had rhegmatogenous RD: 1.1%, 2.5%, 1.6%, and 2.3% of saline, 7.5, 55, and 75 IU treated subjects. Cataracts occurred similarly across treatment groups. No injection-related infectious endophthalmitis was reported. CONCLUSIONS: No serious safety issues were reported after a single intravitreous injection of ovine hyaluronidase. RD incidence was not statistically different between groups. Iritis manifesting as an acute self limited inflammation was the most common adverse event, occurred in a dose response fashion, but was not noted to result in a serious adverse event in any hyaluronidase treated eye.

Pooled efficacy results from two multinational randomized controlled clinical trials of a single intravitreous injection of highly purified ovine hyaluronidase (Vitrase) for the management of vitreous hemorrhage.

PURPOSE: To evaluate the efficacy of intravitreous ovine hyaluronidase for the management of vitreous hemorrhage. DESIGN: Two prospective, randomized, placebo-controlled, double-masked studies. Safety data are presented in a companion article in The Journal. METHODS: Eligible patients with vitreous hemorrhage > or = 1 month duration; severe at entry with best corrected visual acuity (BCVA) worse than 20/200 were randomized to 55 IU or 75 IU ovine hyaluronidase or saline. Primary efficacy (clearance of hemorrhage sufficient to see the underlying pathology and completion of treatment when indicated) was measured at months 1, 2, and 3. Key secondary endpoints were: > or = 3-line improvement in BCVA; hemorrhage density reduction; and therapeutic utility assessment. RESULTS: The intent-to-treat population for common dose groups (55 IU, 75 IU, saline) consisted of 1125 patients. At baseline, 76.3% had diabetes, 90.4% were not able to read any letters on the eye chart, and mean hemorrhage duration was 120 days. Statistical significance was reached in the 55 IU dose group by months 1 and 2 for the primary efficacy endpoint based on an adjusted P-value. By months 1, 2, and 3, 13.2%, 25.5%, and 32.9% of patients (55 IU) reached primary efficacy compared with 5.5%, 16.2%, and 25.6% of saline-treated patients (P < .001; P = .002; P = .025, respectively). Key secondary endpoints confirmed the treatment effect at both doses and all timepoints (P < or = .01). CONCLUSIONS: Fifty-five IU ovine hyaluronidase showed statistically significant efficacy as early as months 1 and 2. These results were supported by outcomes for three key secondary endpoints. These results suggest a therapeutic utility of ovine hyaluronidase in the management of vitreous hemorrhage.

Efficacy of verteporfin photodynamic therapy on laser-induced choroidal neovascularization and the ancillary effect on diabetic microvasculopathy.

PURPOSE: To demonstrate the efficacy of photodynamic therapy (PDT) in treating choroidal neovascularization (CNV) induced by laser photocoagulation for diabetic macular edema and its ancillary effect on surrounding diabetic microvascular abnormalities. METHODS: A retrospective interventional case series study in a clinical practice setting of four patients with proliferative diabetic retinopathy and clinically significant macular edema who had developed classic CNV in proximity to the area of previous laser photocoagulation. The lesions were treated with verteporfin PDT and followed with serial fluorescein angiography. RESULTS: Compared to the pre-treatment angiogram, an acute reduction in leakage from CNV was noted as soon as 5 days post-PDT and persisted in some areas up to three months post-treatment within the zone of the typical dark choroid pattern. No evidence of any closure of microaneurysms was noted. CONCLUSIONS: Serial fluorescein angiograms demonstrate that PDT appears to have a beneficial effect on CNV induced by laser photocoagulation for diabetic macular edema without any tangible beneficial effect on diabetic microvasculopathy. PDT had no effect on existing microaneurysms.

Chronic central serous chorioretinopathy: photodynamic therapy.

PURPOSE: To demonstrate, using optical coherence and fluorescien angiography, the efficacy of photodynamic therapy in treating chronic central serous chorioretinopathy. DESIGN: Interventional case series. METHODS: A retrospective study in a clinical practice setting of four patients (five eyes) with chronic central serous chorioretinopathy. The patients were treated with verteporfin photodynamic therapy and evaluated by optical coherence tomography and fluorescien angiography with average follow-ups of 10 months. RESULTS: Compared to pre-treatment optical coherence tomography, an acute reduction in subretinal fluid accumulation and serous detachment with stoppage of leakage was noted in the five eyes treated. Dramatic improvement in visual acuity was also noted, especially among patients with better vision initially. However, pigmentary changes persisted. CONCLUSION: Serial optical coherence tomography demonstrates that photodynamic therapy with verteporfin appears to have a beneficial effect in treating patients with chronic central serous chorioretinopathy by reducing fluid leakage, subretinal fluid accumulation, and serous detachment with resultant improvement in vision. Better visual results might be expected if photodynamic therapy is applied earlier in the course of the disease.