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

Primary Purpose

Aphakia, Postcataract

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision with dominant eye set at emmetropia and non-dominant eye at -0.50.
Sponsored by
Debbie S. Kuo, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aphakia, Postcataract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Palo Alto Medical FoundationRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mini-Monovision Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Binocular distance is target-corrected visual acuity (VA) at near 40cm.
Increase in ability to see over a broad range of vision without glasses

Secondary Outcome Measures

Full Information

First Posted
April 7, 2023
Last Updated
April 20, 2023
Sponsor
Debbie S. Kuo, MD
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT05821101
Brief Title
Clinical Outcomes of Clareon Vivity Intraocular Lens With Mini-Monovision Approach
Official Title
Clinical Outcomes of Clareon Vivity Intraocular Lens With Mini-Monovision Approach
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 6, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Debbie S. Kuo, MD
Collaborators
Alcon Research

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia, Postcataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mini-Monovision Arm
Arm Type
Experimental
Arm Description
Bilateral implantation of Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision.
Intervention Type
Device
Intervention Name(s)
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 Description
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).
Primary Outcome Measure Information:
Title
Binocular distance is target-corrected visual acuity (VA) at near 40cm.
Description
Increase in ability to see over a broad range of vision without glasses
Time Frame
3 month post-surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sharon De Paz, LVN
Phone
(650) 853-2424
Email
sharontanya.depaz@sutterhealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jimmin Chang, PhD, RN
Phone
(650) 853-5645
Email
jimmin.chang@sutterhealth.org
Facility Information:
Facility Name
Palo Alto Medical Foundation
City
Palo Alto
State/Province
California
ZIP/Postal Code
94301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jimmin Chang
Phone
650-853-5645
Email
Jimmin.Chang@sutterhealth.org
First Name & Middle Initial & Last Name & Degree
Debbie Kuo, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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