Study of Visual Outcomes and Lens Power Optimization After Implanting Monofocal Toric Intraocular Lenses for Cataract Treatment

What this Trial Is About

This research aims to support the safety and performance evaluation of an investigational monofocal toric intraocular lens IOL, focusing on optimizing lens constants based on vision correction outcomes. It involves adults aged 18 years or older who have cataracts and regular corneal astigmatism, scheduled for cataract surgery. The study is a Phase 4 interventional trial sponsored by Carl Zeiss Meditec AG. Participants will receive the investigational device, which is a CE-approved monofocal bitoric, aspheric, aberration-correcting intraocular lens designed to replace the natural cataractous lens and correct corneal astigmatism. The IOL power ranges between 18.0 D to 28.0 D, with cylinder power from 1.0 D to 2.5 D. The study includes unilateral or bilateral implantation during cataract surgery. During the study, participants will undergo preoperative and postoperative assessments up to twelve months, including measurements of refractive predictability, visual acuity, IOL rotation and stability, intraocular pressure, and patient satisfaction. Follow-up evaluations will monitor outcomes such as axis misalignment and spectacle independence. The total participation duration extends to at least twelve months after surgery to capture comprehensive visual outcomes and device performance.

Toric Performance And Constant Evaluation