Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

NCT06924944 | Recruiting

• 1 other identifier: UEC-101-001
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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

Conditions

Correction Vision Surgery; Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• Binocular photopic uncorrected distance VA (at 3 months)

  at 3 months

Secondary Outcomes (1)

• • Binocular photopic uncorrected VA at intermediate (66cm) and near (40cm)

  at 3 months

Other Outcomes (8)

• Monocular uncorrected distance, intermediate, and near VA

  at 3 months

• Monocular and binocular best distance corrected distance, intermediate, and near VA

  at 3 months

• Binocular photopic low contrast distance corrected VA

  at 3 months

Interventions

cataract surgery PROCEDURE

cataract surgery treated with bilateral Clareon Vivity toric and non-toric IOL

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects with bilateral age-related cataract patients with history of myopic refractive surgery (LASIK/PRK)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Utah Eye Centers: lead

Study Sites (1)

Utah Eye Centers

Ogden, Utah, 84403, United States

RECRUITING

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Rachel Buchanan

CONTACT

8014099873; rbuchanan@utaheyecenters.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: April 13, 2025
• Study Start: January 20, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)