Comparative Study Of Intraocular Lenses Visual Performance In Non-Advanced Age-Related Macular Degeneration Patients: Extended Partial Range Of Field Vs. Narrowed

Premium intraocular lenses (IOLs) can enhance visual rehabilitation after cataract surgery across a wide range of patients. However, individuals with retinal diseases, such as age-related macular degeneration (AMD), are often excluded due to their baseline visual impairment and concerns about potential increased side effects. Based on the Range of Field (RoF), the development of purely refractive extended partial RoF (PRoF-Ex) IOLs, which differ from traditional diffractive PRoF-Ex and full RoF IOLs, challenges this perception. Therefore, we conducted a study to compare visual acuity (VA) performance between two types of IOLs—purely refractive PRoF-Ex and narrowed partial RoF (monofocal)—in patients with non-advanced AMD.

Retina and Cataract Clinic of a tertiary reference hospital, presenting interim analysis results from the first cases. The implanted lenses included monofocal (Tecnis DCB00, Johnson & Johnson) and PRoF-Ex (PureSee DENV00, Johnson & Johnson) variants, both from the same IOL platform.

A randomized, double-masked, prospective comparative study was conducted on bilateral cataract patients (VA ≤20/32 Snellen) with early or intermediate AMD (drusen >63 µm and/or pigmentary abnormalities). Exclusion criteria included VA <20/200, endothelial cell count <2000 cells/mm², corneal astigmatism >1 diopter, and axial length <21mm or >26mm. Institutional review board (HCB/2023/0856) approved the study. Patients were randomized to receive either monofocal or PRoF-Ex lenses in both eyes. Postoperative VA (high-contrast and low-contrast (LC VA) Sloan 25%,) was assessed at 45 days for various distances. Variables distributions were analyzed using the Shapiro-Wilk test and T-test for mean comparisons (α = 0.05).

Ten patients (9 women, 1 man) were included (5 PRoF-Ex vs. 5 monofocal), with no significant differences in age (78.8 ± 1.9 PRoF-Ex vs. 77.0 ± 3.0 monofocal, p=0.346) or baseline VA (0.33 ± 0.12 vs. 0.28 ± 0.13, p=0.416). Postoperative uncorrected 4m VA (0.17 ± 0.06 vs. 0.25 ± 0.19, p=0.316) and LC VA (0.48 ± 0.14 vs. 0.46 ± 0.19, p=0.892) showed no differences. PRoF-Ex group had better uncorrected 66cm intermediate VA, but it was not statistically significant (0.34 ± 0.13 vs. 0.45 ± 0.12, p=0.077). Uncorrected 33cm near VA was significantly better in PRoF-Ex (monocular 0.56 ± 0.13 vs. 0.77 ± 0.12, p=0.003; binocular 0.43 ± 0.08 vs. 0.65 ± 0.11, p=0.014). No other significant differences or visually disturbing side effects were reported.

Visual rehabilitation of AMD patients is an increasingly relevant topic, particularly given the rising prevalence of age-related eye disorders. As many of these conditions coexist with visually disturbing cataracts, IOL-based solutions are more feasible and effective. Although based on a limited sample size in this first interim analysis, our findings demonstrate that purely refractive PRoF-Ex lenses in non-advanced AMD patients improve uncorrected near and intermediate VA without compromising distance and LC vision, and without any noticeable visual side effects. These promising results warrant further validation in our larger cohort analysis to confirm their clinical applicability and quality of live benefits.