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

Sponsor

Debbie S. Kuo, MD (Other)

Overall Status

Recruiting

CT.gov ID

NCT05821101

Collaborator

Alcon Research (Industry)

Enrollment

Location

Arm

19.9

Anticipated Duration (Months)

1.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aphakia, Postcataract	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.	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 6, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Binocular distance is target-corrected visual acuity (VA) at near 40cm. [3 month post-surgery]
Increase in ability to see over a broad range of vision without glasses

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palo Alto Medical Foundation	Palo Alto	California	United States	94301

Sponsors and Collaborators

Debbie S. Kuo, MD
Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Debbie S. Kuo, MD, Ophthalmologist, Palo Alto Medical Foundation

ClinicalTrials.gov Identifier:

NCT05821101

Other Study ID Numbers:

IIT# 76030963

First Posted:

Apr 20, 2023

Last Update Posted:

Apr 24, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Aphakia

Aphakia, Postcataract

Study Results

No Results Posted as of Apr 24, 2023