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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
180
Bilateral implantation with Clareon TruPlus
Bilateral implantation with Clareon monofocal
Berkeley Eye Center - Sugar Land
Sugar Land, Texas, United States
RECRUITINGBinocular photopic corrected distance visual acuity (CDVA) at 4 m
Time frame: 3 months postoperatively
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