Status:
NOT_YET_RECRUITING
Vision Improvement for Legally Blind Dry AMD Patients
Lead Sponsor:
Optimal Acuity Corporation
Conditions:
Dry Age-related Macular Degeneration
Vision Impairment and Blindness
Eligibility:
All Genders
50-100 years
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...
Eligibility Criteria
Inclusion
- I
- 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
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04875234
Start Date
January 1 2024
End Date
December 1 2026
Last Update
March 22 2023
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