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

Inclusion criteria

• Adult cataract patients aged ≥22 years scheduled for cataract surgery in both eyes due to visually significant cataracts.
• Ability to understand and sign an IRB/ethics committee-approved informed consent form.
• Willingness and ability to attend all scheduled study visits as required by the protocol and complete all study testing procedures.
• Postoperative potential visual acuity of 20/25 or better in each eye, as determined by the investigator.
• 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 <0.50 D.
• IOL power and, if toric, cylinder availability within labeled ranges for the assigned IOL family.
• Ability to understand and complete study questionnaires.

Exclusion criteria

• Women who are pregnant, planning to become pregnant during the study period, or breastfeeding (by verbal confirmation).
• Ocular conditions that could confound study results, including moderate-to-severe corneal pathology, irregular astigmatism, moderate-to-severe dry eye/ocular surface disease not optimized, preexisting retinal degenerative disease (e.g., age-related macular degeneration), diabetic retinopathy, or other clinically significant retinal pathology.
• Any form of confirmed glaucomatous optic neuropathy or other optic nerve disease expected to affect visual function outcomes.
• History of amblyopia, monofixation syndrome, or other binocular vision disorder with poor stereopsis that could confound binocular testing.
• Prior ocular surgery (including corneal refractive surgery) in either eye.
• Zonular laxity/dehiscence, pseudoexfoliation with clinically significant zonulopathy, nystagmus, or strabismus that could compromise uncomplicated surgery or reliable visual testing.
• Participation in another clinical study (interventional) that could interfere with study results.
• Planned monovision/mini-monovision or desire for monovision targeting.
• Systemic conditions that may affect healing or visual outcomes (e.g., uncontrolled diabetes mellitus, certain autoimmune disorders) per investigator judgment.
• Psychiatric or cognitive disorders that may impair the ability to comply with study procedures or provide reliable self-assessments.
• Any active ocular infection or inflammation.