Phase III Presbyopia Correction Using the VIS Opti-K™ System

Part of paid clinical trials in Boca Raton, Florida.

Sponsor
VIS, Inc.
Study ID
NCT06487897
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Presbyopia

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Optimal laser keratoplasty — DEVICE
    Laser

Study Details

The goal of this clinical trial is to evaluate the safety and efficacy of using the VIS Opti-K System to enable monovision by providing temporary improvement in near vision through the treatment of the non-dominant eye of low myopic, emmetropic and low hyperopic presbyope subjects. The main questions it aims to answer are determining uncorrected near visual acuity at 40cm in the treated eye and subjective improvement as measured by the patient satisfaction questionnaire.

Key Dates

Start date
Sep 30, 2024
Status verified
Aug 2024
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single arm treatment with the VIS Optimal Keratoplasty (Opti-K™) System
    Subjects who accept monovision will receive Opti-K™ treatment in the non-dominant eye. The fellow eye will not receive Opti-K™ treatment in this Pivotal Study. Eligible subjects will undergo a single retreatment

Primary Outcome Measure

Uncorrected near visual acuity 2 or more lines or better [ Time Frame: 3 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Cohen Laser & Vision CenterBoca RatonFlorida33431
Joshua Cohen, M.D.
[email protected]
561-981-8400
Joshua Cohen, M.D. (PRINCIPAL_INVESTIGATOR)
G. Richard Cohen, M.D. (SUB_INVESTIGATOR)
Claris Vision Eye HealthSouth DartmouthMassachusetts02747
Charlotte Friedman
[email protected]
508-994-1400
David Kielty, M.D. (PRINCIPAL_INVESTIGATOR)
The Cornea & Laser Eye InstituteTeaneckNew Jersey07666
Peter Hersh, M.D.
[email protected]
201-692-9434
Peter Hersh, M.D. (PRINCIPAL_INVESTIGATOR)
Steven Greenstein, M.D. (SUB_INVESTIGATOR)
OCLI Vision - OceansideOceansideNew York11572
Isabel Lezcano
[email protected]
516-593-4026
Marguerite McDonald, M.D. (PRINCIPAL_INVESTIGATOR)
Paul Galstein, M.D. (SUB_INVESTIGATOR)

Find similar trials in Boca Raton, FL

By research site
Cohen Laser & Vision Center· Boca Raton, FLClaris Vision Eye Health· South Dartmouth, MAThe Cornea & Laser Eye Institute· Teaneck, NJOCLI Vision - Oceanside· Oceanside, NY

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