Study to Evaluate Safety and Effectiveness of LuxHighAdd Multifocal Intraocular Lens Compared to LuxGood Monofocal Lens in Cataract Patients Aged 50 and Older

What this Trial Is About

Researchers are evaluating the safety and performance of the LuxHighAdd intraocular lens compared with the LuxGood Monofocal lens in people with cataracts. This study involves bilateral implantation of these lenses to replace the cataractous natural lens. The trial aims to assess how well these lenses work and their safety after surgery. Participants will be assigned to one of two groups one group will receive the LuxHighAdd multifocal intraocular lens, while the other group will receive the LuxGood monofocal intraocular lens. Both lenses are implanted in the capsular bag of the eye to replace the cloudy lens. The study does not use random assignment, and both eyes are treated during the procedure. During the study, participants will be followed for 4 to 6 months after surgery. Researchers will measure outcomes such as distance corrected near visual acuity, best corrected distance visual acuity, uncorrected distance, intermediate and near visual acuity, refraction, and contrast sensitivity. They will also assess side effects, including halo and glare, and gather patient feedback through quality of vision and spectacle independence questionnaires. Participants will need to attend all follow-up visits and comply with examination procedures throughout the study.

Multicentric Clinical Investigation to Assess Safety and Performance of Lux HighAdd IOL