NCT06597292
Not yet recruiting
Not Applicable
Vision Improvement for Patients with Presbyopia
VIS, Inc.2 sites in 2 countries200 target enrollmentSeptember 16, 2024
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperopia
- Sponsor
- VIS, Inc.
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Uncorrected Distance Visual Acuity (UDVA)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
The VIS Opti-K Low Vision Aid device will be used to provide vision improvement to patients with refractive disorders (hyperopia and presbyopia).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Uncorrected Distance Visual Acuity (UDVA)
Time Frame: Up to 24 months post-treatment
Uncorrected distance visual acuity (UDVA) is to be measured and reported using standard ETDRS visual acuity charts. UDVA change from baseline is also to be reported.
Uncorrected Near Visual Acuity (UNVA)
Time Frame: Up to 24 months post-treatment
Uncorrected near visual acuity (UNVA) is to be measured and reported using standard near visual acuity charts. UNVA change from baseline is also to be reported.
Study Sites (2)
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