RECRUITING

Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

Quick Facts

Study Start:2025-01-20
Study Completion:2026-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06924944

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * o Bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing uncomplicated bilateral sequential Clareon Vivity IOLs
  2. * Prior history of uncomplicated post-refractive myopic surgery (LASIK/PRK) with up to 1 enhancement treatment
  3. * Potential acuity measured post-operatively 20/25 or better in both eyes
  4. * Patients with regular astigmatism that can be managed with T3 toric lens or arcuate incision
  1. * 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.
  2. * Prior ocular surgeries other than uncomplicated corneal refractive surgery and excluding RK
  3. * Patients with irregular astigmatism/topography (to rule out signs of potential ectasia), corneal dystrophies, and pupil abnormalities
  4. * Total HOA cutoff of ≤0.5, coma ≤0.3
  5. * RLE patients

Contacts and Locations

Study Contact

Rachel Buchanan
CONTACT
8014099873
rbuchanan@utaheyecenters.com

Study Locations (Sites)

Utah Eye Centers
Ogden, Utah, 84403
United States

Collaborators and Investigators

Sponsor: Utah Eye Centers

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-20
Study Completion Date2026-04

Study Record Updates

Study Start Date2025-01-20
Study Completion Date2026-04

Terms related to this study

Additional Relevant MeSH Terms

  • Correction Vision Surgery
  • Cataract Surgery