Real-World Outcomes Of An Extended Macular Vision Iol In Age-Related Macular Degeneration

To determine safety and visual outcomes in eyes with age-related macular degeneration (AMD) implanted with the EyeMax Mono, (SharpView Ophthalmology, London, UK), an extended macular vision intraocular lens (EMV IOL) that delivers an optimized retinal image within 10 degrees of retinal eccentricity.

Seven medical centres in Europe

A multicentre study with real-world evidence (RWE) data collected during the company post-market surveillance. Inclusion criteria were patients with AMD who underwent cataract extraction followed by implantation of EyeMax Mono IOL, a single-piece, injectable, hydrophobic acrylic, EMV IOL. Eyes were categorized according to AMD severity. Outcomes included intraoperative and postoperative complications, post operative spherical equivalent, and pre- and postoperative corrected distance and near visual acuity (CDVA and CNVA, respectively).

The study included 101 eyes of 74 patients. Postoperative spherical equivalent was 1.42±1.4D. Pre- and postoperative CDVA (logMAR) was 0.55±0.36 (n=101) and 0.38±0.32 (n=97), respectively (p<0.001). Pre- and postoperative CNVA (logMAR) was 0.51±0.32 (n=42) and 0.40±0.25 (n=43), respectively (p<0.001). Only 2 eyes lost >1 line of CDVA and none lost lines of CNVA. 55.1% gained >1 line of CDVA, and 27.6% gained ≥ 3 lines of CDVA. 45.2% gained >1 line of CNVA and 19.0% gained ≥ 3 lines of CNVA. The greatest CDVA and CNVA gain was observed in moderate AMD eyes (n=38): 0,23 and 0,18 logMAR gain respectively. Mild AMD eyes (n=37) gained 0.13 and 0.18 logMAR and severe AMD eyes (n=20) gained 0.16 CDVA and 0.06 logMAR of CDVA and CNVA respectively.

The EyeMax Mono intraocular lens (IOL) has been proven safe and effective for enhancing both distant (CDVA) and near (CNVA) visual acuity in patients with age-related macular degeneration, particularly in eyes with moderate AMD. These findings are consistent with the published scientific literature.