Trials / Recruiting
RecruitingNCT06487897
Phase III Presbyopia Correction Using the VIS Opti-K™ System
Phase III Presbyopia Correction Using the VIS Optimal Keratoplasty (Opti-K™) System (Phase IIIa)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- Sponsor
- VIS, Inc. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Optimal laser keratoplasty | Laser |
Timeline
- Start date
- 2024-09-30
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2024-07-05
- Last updated
- 2024-09-05
Locations
4 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06487897. Inclusion in this directory is not an endorsement.