NCT06924944 Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients
| NCT ID | NCT06924944 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Utah Eye Centers |
| Condition | Correction Vision Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 35 participants |
| Start Date | 2025-01-20 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 2025-01-20 with a primary completion date of 2025-12.
⚠ 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
Millions of people have undergone laser vision correction surgery and are motivated to continue with spectacle independence as they develop presbyopia (gradual loss of your eyes' ability to focus on nearby objects)and cataract. However, having a history of refractive surgery, poses challenges in the selection of the IOLs and can lead to visual outcomes that are unpredictable. Data from an international registry and single prospective study show that Vivity IOL provided effective distance, intermediate and near vision in eyes with previous LASIK with minimal effects on day vision associated with the surgery. The purpose of this study is to evaluate the clinical outcomes of post-myopic refractive surgery patients implanted with the Clareon Vivity/Vivity Toric lenses
Eligibility Criteria
Inclusion Criteria: * o Bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing uncomplicated bilateral sequential Clareon Vivity IOLs * Prior history of uncomplicated post-refractive myopic surgery (LASIK/PRK) with up to 1 enhancement treatment * Potential acuity measured post-operatively 20/25 or better in both eyes * Patients with regular astigmatism that can be managed with T3 toric lens or arcuate incision Exclusion Criteria: * o Ocular or systemic comorbidities that may alter or reduce visual acuity and contrast sensitivity such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, etc. * Prior ocular surgeries other than uncomplicated corneal refractive surgery and excluding RK * Patients with irregular astigmatism/topography (to rule out signs of potential ectasia), corneal dystrophies, and pupil abnormalities * Total HOA cutoff of ≤0.5, coma ≤0.3 * RLE patients
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06924944 clinical trial?
This trial is open to participants of all sexes, studying Correction Vision Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06924944 currently recruiting?
Yes, NCT06924944 is actively recruiting participants. Contact the research team at rbuchanan@utaheyecenters.com for enrollment information.
Where is the NCT06924944 trial being conducted?
This trial is being conducted at Ogden, United States.
Who is sponsoring the NCT06924944 clinical trial?
NCT06924944 is sponsored by Utah Eye Centers. The trial plans to enroll 35 participants.