Geographic and socioeconomic access disparities to Phase 3 clinical trials in ophthalmology in the United States.

BACKGROUND/OBJECTIVE: To identify geographic and socioeconomic variables associated with residential proximity to Phase 3 ophthalmology clinical trial sites. METHODS: The geographic location of clinical trial sites for Phase 3 clinical trials in ophthalmology was identified using ClinicalTrials.gov. Driving time from each United States (US) census tract centroid to nearest clinical trial site was calculated using real traffic patterns. Travel data were crosslinked to census-tract level public datasets from United States Census Bureau American Community Survey (ACS). Cross-sectional multivariable regression was used to identify associations between census-tract sociodemographic factors and driving time (>60 min) from each census tract centroid to the nearest clinical trial site. RESULTS: There were 2330 unique clinical trial sites and 71,897 census tracts. Shortest median time was to retina sites [33.7 min (18.7, 70.1 min)]. Longest median time was to neuro-ophthalmology sites [119.8 min (48.7, 240.4 min)]. Driving >60 min was associated with rural tracts [adjusted odds ratio (aOR) 7.60; 95% CI (5.66-10.20), p < 0.0001]; Midwest [aOR 1.84(1.15-2.96), p = 0.01], South [aOR 2.57 (1.38-4.79), p < 0.01], and West [aOR 2.52 (1.52-4.17), p < 0.001] v. Northeast; and tracts with higher visual impairment [aOR 1.07 (1.03-1.10), p < 0.001)]; higher poverty levels [4th v.1st Quartile of population below poverty, aOR 2.26 (1.72-2.98), p < 0.0001]; and lower education levels [high school v. Bachelor's degree or higher aOR 1.02 (1.00-1.03), p = 0.0072]. CONCLUSIONS: There are significant geographic and socioeconomic disparities in access to ophthalmology clinical trial sites for rural, non-Northeastern, poorer, and lower education level census tracts, and for census tracts with higher levels of self-reported visual impairment.

Morphological assessment of the retina in uveitis.

BACKGROUND: The objective of this study is to describe a system for color photograph evaluation in uveitis and report baseline morphologic findings for the Multicenter Uveitis Steroid Treatment (MUST) Trial. Four-hundred seventy-nine eyes of 255 subjects with intermediate, posterior, and panuveitis had stereoscopic color fundus photographs obtained by certified photographers and evaluated by certified graders using standardized procedures to evaluate morphologic characteristics of uveitis. The posterior pole was evaluated for macular edema, vitreoretinal interface abnormalities, and macular pigment disturbance/atrophy; the optic disk was assessed for edema, pallor, or glaucomatous changes. The presence of neovascularization, vascular occlusion, vascular sheathing, and tractional retinal changes was determined. A random subset of 77 images was re-graded to determine the percentage agreement with the original grading on a categorical scale. RESULTS: At baseline, 437/479 eyes had images available to grade. Fifty-three eyes were completely ungradable due to media opacity. Common features of intermediate and posterior/panuveitis were epiretinal membrane (134 eyes, 35 %), and chorioretinal lesions (140 eyes, 36 %). Macular edema was seen in 16 %. Optic nerve head and vascular abnormalities were rare. Reproducibility evaluation found exact agreement for the presence of chorioretinal lesions was 78 %, the presence and location of macular edema was 71 %, and the presence of epiretinal membrane was 71 %. Vertical cup-to-disk ratio measurement had intra-class correlation of 0.75. CONCLUSIONS: The MUST system for evaluating stereoscopic color fundus photographs describes the morphology of uveitis and its sequelae, in a standardized manner, is highly reproducible, and allows monitoring of treatment effect and safety evaluation regarding these outcomes in clinical trials.

Uveitis.

Multidisciplinary management in the diagnosis and management of patients with ocular inflammatory disease is often critical. The workup of uveitis or scleritis may reveal an underlying systemic disease. Recognition of inflammation by the primary care physician can facilitate prompt referral to a uveitis specialist and improve patient outcomes. The primary care physician can assist the ophthalmologist in monitoring for potential side effects of corticosteroids and immunosuppressive drugs, including the newer biologic agents. The ophthalmologist in turn can assist the primary care physician in recognizing that active uveitis may suggest incomplete control of preexisting conditions.

Incidence and management of cataract after retinal detachment repair with silicone oil in immune compromised patients with cytomegalovirus retinitis.

PURPOSE: To determine the incidence of and risk factors for cataract and to describe the visual outcomes of cataract surgery in eyes with cytomegalovirus-related retinal detachments repaired with silicone oil. STUDY DESIGN: Retrospective cohort study. METHODS: A prospectively generated database of all patients with cytomegalovirus retinitis examined at a single tertiary care institution was used to identify all cases of retinal detachment between October 1983 and August 1997. Data on retinal detachment repair, development of cataract, and outcomes of cataract surgery were obtained retrospectively. RESULTS: Among 904 eyes of 587 immune-compromised patients diagnosed with cytomegalovirus retinitis, 198 eyes of 155 patients developed retinal detachment. Among these, 106 eyes of 90 patients underwent retinal detachment repair with silicone oil. The Kaplan-Meier estimated median time to cataract was 1.8 months after surgery with silicone oil. The adjusted relative risk of cataract in eyes that underwent retinal detachment repair with silicone oil compared with eyes that did not was 6.74 (P <.0001). Eight of the eyes that developed cataract underwent uncomplicated cataract surgery by phacoemulsification and posterior chamber intraocular lens implantation. Among these, six eyes experienced >or=2 lines of improvement in visual acuity. All developed posterior capsule opacification a median of 7 days after cataract surgery. Four of five eyes that that underwent neodymium:yttrium-aluminum-garnet laser capsulotomy experienced >or=2 lines improvement in visual acuity. CONCLUSIONS: There is a high incidence of cataract after surgery with silicone oil tamponade for cytomegalovirus-related retinal detachment. Posterior capsule opacification occurs rapidly after cataract surgery in these patients.