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NCT07610226Recruiting

Post-refractive IOL Outcomes With Clareon TruPlus

Laser Defined Vision

Start Date

6/25/2026

Completion Date

6/23/2027

Summary

This is a prospective, single-arm, single-center, single-surgeon study evaluating the Clareon TruPlus IOL in post-refractive cataract patients. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the PRISQ Questionnaire.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Willing and able to understand and sign informed consent. * Adult patients (\>45 years old) undergoing age-related cataract surgery that previously had myopic corneal refractive surgery. * Dominant eye targeted for emmetropia, non-dominant eye may be targeted for ≤-0.75D (mini-monovision). * Best monocular corrected distance visual acuity expected to be 0.1 logMAR (Snellen 20/25) or better in both eyes pre-operatively as determined by surgeon. * Normal ocular findings aside from cataract. Exclusion Criteria: * Moderate-severe corneal pathology, irregular astigmatism, preexisting macular disease and other retinal degenerative diseases, diabetic retinopathy that is expected to cause future vision loss, glaucoma, severe dry eye disease, nystagmus, strabismus, zonular laxity or dehiscence, pseudoexfoliation. * Previous history of any ocular surgery, except for myopic LASIK or PRK. * Previous hyperopic refractive surgery. * Corneal HOA ≥1.0 µm (RMS) with OPD at 4mm scan. * Any active ocular infection or inflammation.

Interventions

DEVICE

Clareon TruPlus

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Conditions

Cataract

Locations

Physicians Protocol

Greensboro, North Carolina 27401

United States