Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

Recruiting

• Conditions: Correction Vision Surgery; Cataract Surgery

• Registration Number: NCT06924944
• Lead Sponsor: Utah Eye Centers

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-01-20
• Study First Submitted: 2025-01-22
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-13
• Last Update Posted: 2025-04-13
• Primary Completion: 2025-12
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Binocular photopic uncorrected distance VA (at 3 months)	at 3 months

Secondary Outcome Measures

Name	Time	Method
• Binocular photopic uncorrected VA at intermediate (66cm) and near (40cm)	at 3 months

Trial Locations

Locations (1)

Utah Eye Centers; 🇺🇸 Ogden, Utah, United States