Clinical Outcomes of Bilateral Clareon Vivity in Post-Refractive Patients

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

Study Overview

• Status: Recruiting
• Conditions: Cataract Surgery; Correction Vision Surgery
• Intervention / Treatment: Procedure: cataract surgery

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Rachel Buchanan; Phone Number: 8014099873; Email: rbuchanan@utaheyecenters.com

Study Locations

• United States
  • Utah
    • Ogden, Utah, United States, 84403
      • Recruiting
      • Utah Eye Centers
      • Contact: Rachel Buchanan; Phone Number: 8014099873; Email: rbuchanan@utaheyecenters.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binocular photopic uncorrected distance VA (at 3 months)	at 3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
• Binocular photopic uncorrected VA at intermediate (66cm) and near (40cm)	at 3 months

Other Outcome Measures

Outcome Measure	Time Frame
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
Mean refractive spherical equivalent (MRSE) for dominant and non-dominant eye	at 3 months
Mean difference of MRSE between dominant and non-dominant eye	at 3 months
% of eyes with absolute prediction error less than or equal to 0.5D	at 3 months
Visual disturbances via QUVID questionnaire	at 3 months
Potential association between HOA (SA and coma) and monocular DCVAs	at 3 months

Collaborators and Investigators

• Sponsor: Utah Eye Centers

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2025
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: January 22, 2025
• First Submitted That Met QC Criteria: April 9, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 9, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: UEC-101-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes