Study of Clareon TruPlus Monofocal Intraocular Lenses for Cataract Surgery in Adults

What this Trial Is About

This research study aims to gather safety and performance data for Clareon TruPlus Monofocal Intraocular Lenses IOLs, which are devices implanted in the eye during cataract surgery to restore clear vision after removal of the cloudy natural lens. The study focuses on patients diagnosed with bilateral cataracts, including those with astigmatism suitable for correction with toric IOL models. The lenses are intended to remain in the eyes for the patients lifetime. Participants will be implanted with either the Clareon TruPlus Monofocal Non-Toric or Toric IOL based on recommendations from an IOL calculator. The cataract surgery uses a minimally invasive technique called phacoemulsification to remove the natural lens before implantation. The study includes one preoperative visit, two surgical visits with the second eye surgery occurring 0 to 14 days after the first, and five postoperative visits, spanning approximately 13 months of participation. Throughout the study, participants will undergo assessments of binocular photopic best corrected distance visual acuity BCDVA at preoperative day 0 and at 1, 3, and 12 months after surgery. Researchers will monitor vision outcomes and the performance of the implanted lenses. The study involves regular follow-up visits and evaluations to ensure participant safety and to collect detailed data on visual acuity over time.

Clareon TruPlus Study