Vision Improvement for Legally Blind Dry Age-Related Macular Degeneration Patients

Optimal Acuity Corporation0 sites40 target enrollmentJanuary 2024

ConditionsDry Age-related Macular Degeneration Vision Impairment and Blindness

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry Age-related Macular Degeneration
Sponsor: Optimal Acuity Corporation
Enrollment: 40
Primary Endpoint: Best spectacle-corrected distance visual acuity (BCDVA)
Status: Not yet recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2024

End Date

December 2026

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Optimal Acuity Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or Female
•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