Abstract
Purpose :
Enhanced peripheral vision (EPV) intraocular lens (IOL) fully compensates for the average corneal spherical aberration in comparison to a monofocal IOL. The purpose of the study is to evaluate the clinical performance and peripheral refractive error of an EPV IOL, compared to a standard monofocal IOL.
Methods :
Data was collected on 30 subjects implanted with EPV IOL in one eye and monofocal control IOL in the other eye to evaluate the clinical outcomes of distance visual acuity and the relative peripheral astigmatism and blur. Best corrected distance visual acuity (BCDVA) was measured under three conditions: 1) photopic high contrast (primary endpoint), 2) mesopic high contrast and 3) mesopic low contrast (10%), and the relative peripheral astigmatism (co-primary endpoint) and the relative peripheral blur was measured with an open field autorefractor in steps of 10 degrees from 30 degrees nasal to 30 degrees temporal. The incidence of visual symptoms was recorded.
Results :
At 6 months, 72.4% of EPV eyes and 69.0% of control eyes had an absolute manifest refraction spherical equivalent within 0.50 D. The mean LogMAR best corrected distance acuity (SD) results of EPV IOL vs control IOL were: 0.01 (0.08) vs -0.03 (0.11), 0.13 (0.10) vs 0.10 (0.10) and 0.67 (0.23) vs 0.63 (0.15) for the conditions of photopic high contrast, mesopic high contrast and mesopic low contrast, respectively. The primary endpoint of non-inferiority in mean BCDVA difference was met, as the lower limit of the 2-sided 90% confidence interval was -0.065. A reduction in peripheral astigmatism and peripheral blur for the EPV IOL was found for all measured field points. The co-primary endpoint of lower mean nasal field astigmatism at 20° for EPV IOL eyes compared to control eyes was met (p<0.0001) with a mean reduction of 1.6D (SD=1.51). The reported incidence of visual symptoms was similar between both IOLs.
Conclusions :
This study demonstrates that the EPV IOL provides similar central vision in photopic and mesopic light and under mesopic low contrast conditions while reducing peripheral astigmatism and peripheral blur compared to the monofocal control IOL to enhance peripheral vision.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.