Actively Recruiting
Clinical Outcomes of Bilateral Clareon Vivity in Patients After Myopic Refractive Surgery
Led by Utah Eye Centers · Updated on 2025-04-13
35
Participants Needed
1
Research Sites
17 weeks
Total Duration
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AI-Summary
What this Trial Is About
Millions of people who have had laser vision correction surgery are interested in maintaining their independence from glasses as they develop presbyopia and cataracts. However, previous refractive surgery can make selecting the right intraocular lenses (IOLs) challenging and may lead to unpredictable visual outcomes. Researchers are evaluating the clinical results of using Clareon Vivity and Vivity Toric lenses in patients who previously had myopic refractive surgery to better understand their effectiveness. Participants in this observational study will undergo cataract surgery treated with bilateral Clareon Vivity toric and non-toric IOLs. The study focuses on patients who have had uncomplicated post-refractive myopic surgery, such as LASIK or PRK, possibly with one enhancement treatment. The lenses are designed to provide effective distance, intermediate, and near vision while minimizing visual disturbances related to surgery. During the study, researchers will measure binocular photopic uncorrected distance visual acuity at three months after surgery, along with uncorrected vision at intermediate and near distances. The study monitors vision outcomes and evaluates how well the lenses perform in patients with prior refractive surgery. Participants will be followed for at least three months to assess these visual measures and overall results.
CONDITIONS
Brief Title
Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Bilateral age-related visually significant cataracts in otherwise healthy eyes
- Undergoing uncomplicated bilateral sequential Clareon Vivity intraocular lens implantation
- Prior history of uncomplicated post-refractive myopic surgery (LASIK or PRK) with up to one enhancement treatment
- Potential visual acuity measured post-operatively of 20/25 or better in both eyes
- Patients with regular astigmatism manageable with T3 toric lens or arcuate incision
You will not qualify if you...
- Ocular or systemic conditions that may reduce visual acuity or contrast sensitivity, including severe dry eye, ocular surface disease, glaucoma, macular degeneration, retinopathy, or neuro-ophthalmic diseases
- Prior ocular surgeries other than uncomplicated corneal refractive surgery; excludes radial keratotomy (RK)
- Irregular astigmatism or topography indicating potential ectasia
- Corneal dystrophies or pupil abnormalities
- Total higher order aberrations (HOA) greater than 0.5 or coma greater than 0.3
- Patients who have had refractive lens exchange (RLE) procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 1 week
Participants undergo cataract surgery treated with bilateral Clareon Vivity toric and non-toric intraocular lenses, followed by immediate post-operative assessments.
1 surgery visit and approximately 1 post-operative visit
Duration - 3 months
Participants are monitored for visual acuity outcomes and recovery after surgery.
Approximately 3 follow-up visits
Trial Site Locations
Total: 1 location
1
Utah Eye Centers
Ogden, Utah, United States, 84403
Actively Recruiting
Research Team
R
Rachel Buchanan
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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