Visual Outcomes And Patient Satisfaction Following Implantation Of A New Hydrophobic Monofocal Iol: 3-Month Interim Report

To evaluate the visual performance and patient satisfaction following implantation of a new hydrophobic, non-constant aberration correcting, aspheric, monofocal IOL (CT LUCIA 621P).

Ongoing post-approval study conducted in 3 centers across the United States.

Patients received the abovementioned monofocal IOL following cataract or refractive lens exchange surgery. Outcomes evaluated in this study included monocular/binocular, photopic/mesopic, corrected/uncorrected, distance/intermediate visual acuities (VAs) in Snellen, defocus curves in LogMAR, manifest refractive spherical equivalent (MRSE), refractive predictability, and patient satisfaction (using visual function questionnaire, VFQ-25). Outcomes were assessed at 1 day, 1 week, 1 month and 3 months following IOL implantation.

Thirty eyes from 15 patients were included in this 3-month interim analysis. Most distance and intermediate VAs were 20/40 or better. Monocular and binocular defocus curves showed that VA was better than 0.2 LogMAR between -0.5 and 0.5 D under both photopic and mesopic conditions. Mean MRSE was -0.1 ± 0.27 D at 1-month and -0.2 ± 0.31 D at 3-months. Moreover, 98.3% of patients achieved an MRSE within ±0.50 D. Mean scores for VFQ-25 were 86.7 ± 10.78 points at 1-month and 89.3 ± 6.00 points at 3-months, corresponding to an increase of ~23 and ~30 points compared to baseline, respectively. Mean scores for distance activities also increased by ~27 points at 1-month and ~38 points at 3-months compared to baseline.

Results of this interim analysis suggest that CT LUCIA 621P can provide good visual and refractive outcomes with a high patient satisfaction up to 3 months following implantation.