Clinical Outcomes of Clareon Vivity Intraocular Lens With Mini-Monovision Approach

NCT05821101 | Active Not Recruiting FDA Device

• 1 other identifier: IIT# 76030963
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose is to study the clinical outcomes of Clareon Vivity and Clareon Vivity Toric intraocular lens (IOL) implants in patients who are planning to have cataract surgery in both eyes with a mini-monovision approach.

Conditions

Aphakia, Postcataract

Outcome Measures

Primary Outcomes (1)

• Binocular distance is target-corrected visual acuity (VA) at near 40cm.

  Increase in ability to see over a broad range of vision without glasses

  3 month post-surgery

Study Arms (1)

Mini-Monovision Arm

EXPERIMENTAL

Bilateral implantation of Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision.

Device: Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision with dominant eye set at emmetropia and non-dominant eye at -0.50.

Interventions

Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision with dominant eye set at emmetropia and non-dominant eye at -0.50. DEVICE

Bilateral implantation of IOLs such that dominant eye is corrected for distance vision while the non-dominant eye is corrected with a small amount of nearsightedness (-0.5 diopters).

Mini-Monovision Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with bilateral age-related visually significant cataracts in otherwise healthy eyes, undergoing bilateral sequential implantation within 21 days using Clareon Vivity and Clareon Vivity Torics
• IOL powers between +10D to +30.0D, T3-T6
• Potential acuity measured post-operatively 20/25 or better in both eyes

You may not qualify if:

• History of ocular or refractive surgery
• Ocular or systemic comorbidities that may alter or reduce visual acuity, contrast sensitivity, binocularity, or impair reading performance such as severe dry eye/ocular surface disease, glaucoma, macular degeneration, retinopathy, neuro-ophthalmic diseases, strabismus/amblyopia etc.
• Patients with irregular astigmatism, corneal dystrophies, pupil abnormalities, zonular laxity
• Intraoperative or postoperative complications

Sponsors & Collaborators

• Debbie S. Kuo, MD: lead
• Alcon Research: collaborator

Study Sites (1)

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

MeSH Terms

Conditions

Aphakia, Postcataract

Condition Hierarchy (Ancestors)

Aphakia; Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ophthalmologist

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: April 6, 2023
• Primary Completion: January 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)