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

Last updated: July 1, 2025
Sponsor: Debbie S. Kuo, MD
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

N/A

Treatment

Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision with dominant eye set at emmetropia and non-dominant eye at -0.50.

Clinical Study ID

NCT05821101
IIT# 76030963
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adult patients with bilateral age-related visually significant cataracts inotherwise healthy eyes, undergoing bilateral sequential implantation within 21 daysusing 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

Exclusion Criteria:

  • History of ocular or refractive surgery

  • Ocular or systemic comorbidities that may alter or reduce visual acuity, contrastsensitivity, binocularity, or impair reading performance such as severe dryeye/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

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Clareon Vivity and Clareon Vivity Toric IOLs targeted for mini-monovision with dominant eye set at emmetropia and non-dominant eye at -0.50.
Phase:
Study Start date:
April 06, 2023
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • Palo Alto Medical Foundation

    Palo Alto, California 94301
    United States

    Site Not Available

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