NCT07648355 Visual and Patient Reported Outcomes With Clareon TruPlus
| NCT ID | NCT07648355 |
| Status | Recruiting |
| Phase | — |
| Sponsor | OVO LASIK + Lens |
| Condition | Cataract |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2027-07-11 |
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 40 participants in total. It began in 2026-06-02 with a primary completion date of 2027-07-11.
⚠ 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-site, two-surgeon, single-arm, observational study evaluating the Clareon TruPlus IOL. Subjects will be assessed up to 3 months post-operatively. Clinical evaluations will include refractive outcomes, visual acuity, and administration of the IOLSAT Questionnaire.
Eligibility Criteria
Inclusion Criteria: * Willing and able to understand and sign informed consent. * Adult patients (\>40 years old) undergoing age-related cataract surgery with expected best-corrected visual outcomes of 20/25 or better in both eyes pre-operatively as determined by surgeon and with regular corneal astigmatism correctable to less than 0.75 diopters post-operatively with no more than a T6 toric power IOL. * Normal ocular findings aside from cataract and mild dry eye. Exclusion Criteria: * Subjects targeted for monovision. * 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, amblyopia, zonular laxity or dehiscence, pseudoexfoliation. * Previous history of any ocular surgery including LASIK (excluding minor lid procedures). * Patients with irregular astigmatism/topography, corneal dystrophies, and pupil abnormalities. * Participation in another clinical study that could interfere with the results. * Any active ocular infection or inflammation.
Contact & Investigator
Martha Whiting, MD
PRINCIPAL INVESTIGATOR
OVO Lasik and Lens LLC
Frequently Asked Questions
Who can join the NCT07648355 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 NCT07648355 currently recruiting?
Yes, NCT07648355 is actively recruiting participants. Contact the research team at ashley.prepeluh@ovoeye.com for enrollment information.
Where is the NCT07648355 trial being conducted?
This trial is being conducted at Saint Louis Park, United States.
Who is sponsoring the NCT07648355 clinical trial?
NCT07648355 is sponsored by OVO LASIK + Lens. The principal investigator is Martha Whiting, MD at OVO Lasik and Lens LLC. The trial plans to enroll 40 participants.