Recruiting

Clareon Vivity

Sponsor:

Utah Eye Centers

Code:

NCT06924944

Conditions

Correction Vision Surgery

Cataract Surgery

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

cataract surgery

Study Details

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

Study ID

NCT06924944

Start date

Jan 20, 2025

Status verified date

Apr, 2025

Completion date

Apr, 2026

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Interventions

cataract surgery

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

Primary outcome measure

  • Binocular photopic uncorrected distance VA (at 3 months) [ Time Frame: at 3 months ]

Central Contacts and Locations

Central contacts

Rachel Buchanan

8014099873rbuchanan@utaheyecenters.com

Locations

Utah Eye Centers

Recruiting

Ogden, Utah, United States, 84403

Contacts

Rachel Buchanan

8014099873rbuchanan@utaheyecenters.com

More Information

Sponsor

Utah Eye Centers

Last update posted

Apr 13, 2025

Last verified

Apr, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Utah Eye Centers on 2025-04-13.