Multicenter clinical trial
Recruitment in the multicenter clinical trial started in October 2015. The trial is under way in seven centers in six European countries. Planned enrollment is 60 eyes. So far, 35 eyes have been implanted, and Dr. Srinivasan presented data from 25 eyes that had completed 1 year of follow-up.
Patients were eligible for enrollment if they were at least 55 years old, were pseudophakic, and had dry or inactive, stable wet AMD. They had to have corrected distance visual acuity (CDVA) of 0.1 to 0.4 (decimal) and show improvement in corrected near visual acuity (CNVA) of ≥3 lines when tested with a +6.0 D reading addition at 15 cm, compared to a +2.5 D add at 40 cm. The testing was performed at all centers with standardized ETDRS near vision charts.
Patients were excluded if they had active wet AMD, severe zonulopathy, iris neovascularization, uveitis, anterior chamber depth <2.8 mm from the endothelium, or had previous complicated cataract surgery.