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

Aphakia, Postcataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05821101
• Other study ID #: IIT# 76030963
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2023
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: Palo Alto Medical Foundation
• Contact: Sharon De Paz, LVN
• Phone: (650) 853-2424
• Email: sharontanya.depaz[@]sutterhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphakia
• Aphakia, Postcataract

Intervention

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.
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).

Locations

Country	Name	City	State
United States	Palo Alto Medical Foundation	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Debbie S. Kuo, MD	Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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