gms | German Medical Science

Purpose: To determine the 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.

Methods: 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 the EyeMax Mono IOL, a single-piece, injectable, hydrophobic acrylic EMV IOL. Eyes were categorized according to AMD severity. Outcomes included intraoperative and postoperative complications, postoperative spherical equivalent (SE), and pre- and postoperative corrected distance and near visual acuity (CDVA and CNVA, respectively).

Results: The study included 101 eyes of 74 patients. Postoperative SE was 1.42 ± 1.4 D. 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). Two eyes lost >1 line of CDVA, and none lost lines of CNVA. 27.6% gained ≥3 lines of CDVA. Additionally, 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 logMAR in CDVA and 0.06 logMAR in CNVA, respectively.

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