The VIS Opti-K Low Vision Aid Device Provide Vision Improvement.

Not Applicable

Not yet recruiting

• Conditions: Hyperopia; Presbyopia
• Interventions: Device: Vision improvement

• Registration Number: NCT06597292
• Lead Sponsor: VIS, Inc.

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-30
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study Start: 2024-09-16
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-09-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Not provided

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Vision improvement	Vision improvement	-

Primary Outcome Measures

Name	Time	Method
Uncorrected Distance Visual Acuity (UDVA)	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)	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.

Trial Locations

Locations (2)

VIS, Inc.; 🇺🇸 Austin, Texas, United States

Clarity Eye Institute; 🇨🇦 Toronto, Ontario, Canada