Comparing Bilateral Clareon TruPlus and Clareon Monofocal Intraocular Lens Implantation for Cataract Surgery in Adults 22 Years and Older

What this Trial Is About

Researchers are conducting a prospective, randomized study to compare two types of intraocular lenses IOLs, Clareon TruPlus and Clareon monofocal, in adults aged 22 years and older who require cataract surgery in both eyes. This study is designed with a parallel-group and double-masked approach, where participants and examiners will not know which lens was implanted, while surgeons will be aware. The primary goal is to evaluate vision outcomes at 3 months after surgery. Participants will receive bilateral implantation of either the Clareon TruPlus or the Clareon monofocal IOL, with spherical and toric models allowed based on standardized preoperative planning and clinical needs. The study uses a randomized assignment to either lens type, and both spherical and toric versions will be used depending on the patients corneal astigmatism and other factors. The study spans from preoperative planning through at least 3 months post-surgery to assess outcomes. During the study, participants will attend scheduled visits for eye exams and testing, including measurement of binocular corrected distance visual acuity at 4 meters three months after surgery. They will complete study questionnaires and undergo clinical evaluations to monitor their vision and eye health. Safety and vision outcomes will be closely followed throughout the study period, which lasts until July 2027.

A Prospective, Randomized, Subject- and Examiner-Masked, Multicenter Study Comparing Bilateral Clareon TruPlus and Bilateral Clareon Monofocal Intraocular Lens Implantation (Spherical and Toric) in Cataract Subjects