Vision Improvement for Legally Blind Dry AMD Patients

Not yet recruiting

• Conditions: Vision Impairment and Blindness; Dry Age-related Macular Degeneration
• Interventions: Device: Clear-K Low Vision Aid Treatment

• Registration Number: NCT04875234
• Lead Sponsor: Optimal Acuity Corporation

Brief Summary

This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry AMD patients.

Detailed Description

This retrospective observational study is intended to assess the feasibility of using a nonsignificant risk device for vision improvement for legally blind dry Age-Related Macular Degneration patients. 12-month follow-up examinations will be used to assess the amount of vision improvement and its dependence on device parameters.

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-05
• Study First Posted: 2021-05-06
• Status Verified: 2022-04
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22
• Study Start: 2024-01
• Primary Completion: 2025-07
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Male or Female
• Any race
• Patient is at least 50 years old.
• Patient must have dry AMD in the study eye.
• Patient is legally blind due to AMD - i.e., has corrected distance visual acuity (CDVA) of 20/125 or worse (45 letters; logMAR ≥ 0.80) in the study eye.
• Patient has normal corneal surface topography on videokeratography (i.e., without distorted or unclear corneal mires).
• Patient is not a contact lens wearer.
• Patient is willing and able to comply with all examinations.
• Patient must be competent to sign an informed consent form before study entry.

Exclusion Criteria

• Visually significant cataract in the study eye
• Presence of a visually significant posterior capsule opacity if prior cataract surgery has been performed in the study eye
• Any visually significant disease process in any ocular structure other than AMD that would affect vision in the study eye
• Previous corneal surgery in the study eye
• Presence or history of any other condition or finding that, in the opinion of the investigator, makes the patient unsuitable as a candidate for study participation or may confound the outcome of the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Legally Blind Dry AMD Patients	Clear-K Low Vision Aid Treatment	Legally Blind Dry AMD Patients with either unilateral or bilateral blindness

Primary Outcome Measures

Name	Time	Method
Best spectacle-corrected distance visual acuity (BCDVA)	12 months post-treatment	BCDVA measured using ETDRS eye charts