NCT07610226 Post-refractive IOL Outcomes With Clareon TruPlus
| NCT ID | NCT07610226 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laser Defined Vision |
| Condition | Cataract |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2026-06-25 |
| Primary Completion | 2027-06-23 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 35 participants in total. It began in 2026-06-25 with a primary completion date of 2027-06-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Karl Stonecipher, MD
PRINCIPAL INVESTIGATOR
Physicians Protocol
Frequently Asked Questions
Who can join the NCT07610226 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07610226 currently recruiting?
Yes, NCT07610226 is actively recruiting participants. Visit ClinicalTrials.gov or contact Laser Defined Vision to inquire about joining.
Where is the NCT07610226 trial being conducted?
This trial is being conducted at Greensboro, United States.
Who is sponsoring the NCT07610226 clinical trial?
NCT07610226 is sponsored by Laser Defined Vision. The principal investigator is Karl Stonecipher, MD at Physicians Protocol. The trial plans to enroll 35 participants.