Bicentric Clinical Investigation to Assess Safety and Performance of a Hydrophobic Acrylic Enhanced Monofocal Intraocular Lens.

What this Trial Is About

This research aims to evaluate the safety and performance of bilateral implantation of LuxBoost intraocular lenses compared with the LuxGood Monofocal lens in patients with aphakia. The study focuses on assessing how well these lenses function in replacing the cataractous human crystalline lens and their impact on visual acuity. The trial is sponsored by Cutting Edge SAS and involves adult participants aged 50 years and older who are planned for posterior chamber intraocular lens implantation due to bilateral cataracts. Participants are randomly assigned to receive either the LuxBoost intraocular lens or the LuxGood parent intraocular lens. Both lenses are hydrophobic acrylic monofocal intraocular devices implanted bilaterally in the capsular bag to replace the natural lens. The study does not use masking or blinding. The main evaluation period occurs 4 to 6 months after surgery to compare the outcomes between the two groups. During the study, participants will undergo various eye examinations including measurements of best corrected distance visual acuity, uncorrected distance and near visual acuity, and defocus curve assessments at 4 and 6 months post-surgery. Researchers will monitor lens performance and safety throughout follow-up visits. Participants must be willing and able to comply with all study procedures and attend all follow-up visits. The total participation timeline includes pre-surgical assessments, implantation, and several months of monitoring after surgery.

Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL