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

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.

Study Overview

• Status: Recruiting
• Conditions: Aphakia, Postcataract
• Intervention / Treatment: 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.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sharon De Paz, LVN; Phone Number: (650) 853-2424; Email: sharontanya.depaz@sutterhealth.org
• Study Contact Backup: Name: Jimmin Chang, PhD, RN; Phone Number: (650) 853-5645; Email: jimmin.chang@sutterhealth.org

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94301
      • Recruiting
      • Palo Alto Medical Foundation
      • Contact: Jimmin Chang; Phone Number: 650-853-5645; Email: Jimmin.Chang@sutterhealth.org
      • Principal Investigator: Debbie Kuo, MD

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mini-Monovision Arm; 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.; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Debbie S. Kuo, MD
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2023
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2024

Study Registration Dates

• First Submitted: April 7, 2023
• First Submitted That Met QC Criteria: April 7, 2023
• First Posted (Actual): April 20, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Aphakia; Aphakia, Postcataract
• Other Study ID Numbers: IIT# 76030963

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: Yes
• product manufactured in and exported from the U.S.: Yes