Subthreshold Nanosecond Laser Intervention in Intermediate Age-Related Macular Degeneration: Study Design and Baseline Characteristics of the Laser in Early Stages of Age-Related Macular Degeneration Study (Report Number 1)

摘要: Purpose The Laser Intervention in Early Stages of Age-Related Macular Degeneration (LEAD) study is an investigation the safety and efficacy subthreshold nanosecond laser treatment to slow progression intermediate age-related macular degeneration (AMD). This report presents novel design baseline characteristics. Design Multicenter, double-masked, randomized controlled, medical device feasibility clinical trial. Participants Persons with bilateral drusen >125 μm within 1500 fovea, monocular best-corrected visual acuity (BCVA) ≥20/40, microperimetric retinal sensitivity Methods were or sham treatment. Twelve spots are applied region eye. reviewed visits every 6 months functional testing MMI for 36 re-treated at each visit (until 30 months) if end point not reached Main Outcome Measures Progression late AMD MMI-defined anatomic points Results A total 292 participants across centers enrolled, 145 arm 1 147 2. Population characteristics as follows: median age 70 years, 73% female, 90% Anglo-Saxon, 3% current smokers. Baseline ocular eyes BCVA 83 letters (20/25); low luminance (LLVA) 68 (20/50); hyperpigmentation, 33%; reticular pseudodrusen, 23%; square root area (SD-OCT), 0.77 mm; (color photographs), 0.92 mm; cube volume 0.26 average sensitivity, 26 dB; worst 20 dB. Only lutein supplement use was significantly different between arms. Conclusions LEAD uses inclusion/exclusion criteria attempt optimize our design. Risk equally distributed