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

This investigator-initiated trial is a prospective, randomized, parallel-group, bilateral implantation study comparing Clareon TruPlus versus Clareon monofocal intraocular lenses (IOLs). Spherical and toric models are permitted in both arms based on standardized preoperative planning and clinical indication. Subjects and postoperative examiners/technicians will be masked to IOL assignment; surgeons will not be masked. The overall structure is modeled after randomized bilateral implantation cataract study designs with a Month 3 primary endpoint visit.

Inclusion Criteria: 1. Adult cataract patients aged ≥22 years scheduled for cataract surgery in both eyes due to visually significant cataracts. 2. Ability to understand and sign an IRB/ethics committee-approved informed consent form. 3. Willingness and ability to attend all scheduled study visits as required by the protocol and complete all study testing procedures. 4. Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator. 5. Preoperative corneal astigmatism that can be corrected with a T3-T5 toric IOL, or with a spherical IOL plus LRIs/Aks, with either resulting in a predicted postoperative astigmatism \