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

NCT ID: NCT05821101

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-06
• Study Completion Date: 2026-06-30

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.

Detailed Description

A "mini-monovision" approach is one in which the dominant eye is corrected for distance vision while the non-dominant eye is corrected with a small amount of nearsightedness (-0.5 diopters). This approach can have the benefit of increasing ability to see over a broad range of vision without glasses. The Clareon Vivity and Vivity Toric lenses have been approved by the U.S. Food and Drug Administration (FDA) for visual correction of aphakia in adult patients following cataract surgery. It has lens technology that provides an extended depth of focus (more range of clear vision for distance, intermediate and near vision) compared to a standard monofocal (single focus) lens. None of the procedures in this study are experimental. However, the study is seeking additional information on clinical outcomes of the mini-monovision approach specifically using the Clareon Vivity and Vivity Toric lenses.

Conditions

Aphakia, Postcataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mini-Monovision Arm

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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).

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.

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Debbie S. Kuo, MD

OTHER

Sponsor Role: lead

Responsible Party

Debbie S. Kuo, MD

Ophthalmologist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Palo Alto Medical Foundation

Palo Alto, California, United States

Countries

United States

Other Identifiers

IIT# 76030963

Identifier Type: -

Identifier Source: org_study_id