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Recruiting NCT07610226

Post-refractive IOL Outcomes With Clareon TruPlus

Conditions: Cataract

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 35
Sponsor: Laser Defined Vision

Location: Physicians Protocol Greensboro North Carolina

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

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07610226). StuddyBuddy aggregates publicly available trial information.