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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05821101
Other study ID # IIT# 76030963
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT04005651 - Safety and Efficacy of a Trifocal Intraocular Lens (IOL) POD L GF in Comparison With a Multifocal and a Monofocal IOL N/A
Recruiting NCT06363448 - Yamani Technique Versus Proline Mesh for Intraocular Lens Scleral Fixation in Aphakia N/A