Evaluating outcomes of Clareon Vivity lenses in patients with previous vision correction surgery
Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients
This study is testing how well Clareon Vivity lenses work for people with age-related cataracts who have previously had vision correction surgery like LASIK or PRK.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 35 (estimated) |
| Sex | All |
| Sponsor | Utah Eye Centers Academic / other |
| Locations | 1 site (Ogden, Utah) |
| Trial ID | NCT06924944 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the clinical outcomes of patients who have undergone bilateral cataract surgery using Clareon Vivity intraocular lenses (IOLs) after having previous myopic refractive surgery, such as LASIK or PRK. The study focuses on patients with age-related cataracts who are otherwise healthy and have a history of uncomplicated refractive surgery. By analyzing visual acuity and other outcomes post-surgery, the study seeks to provide insights into the effectiveness of these lenses in achieving good vision at various distances. The research is based on data from an international registry and aims to address the challenges faced by post-refractive surgery patients in achieving predictable visual outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with bilateral age-related cataracts who have previously undergone uncomplicated myopic refractive surgery and meet specific visual acuity criteria.
Not a fit: Patients with significant ocular or systemic comorbidities that could affect visual acuity or contrast sensitivity are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of how Clareon Vivity lenses perform in patients with a history of refractive surgery, potentially leading to improved visual outcomes and greater spectacle independence.
How similar studies have performed: While this study builds on existing data regarding the effectiveness of Vivity IOLs, it specifically targets a unique patient population, making it a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ogden, Utah
- Utah Eye Centers — Ogden, Utah, United States (Recruiting)
Study contacts
- Study coordinator: Rachel Buchanan
- Email: rbuchanan@utaheyecenters.com
- Phone: 8014099873
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.