Vision Improvement for Legally Blind Dry AMD Patients

Optimal Acuity

Status

Not yet enrolling

Conditions

Vision Impairment and Blindness

Dry Age-related Macular Degeneration

Treatments

Device: Clear-K Low Vision Aid Treatment

Study type

Observational

Funder types

Industry

Identifiers

NCT04875234

Retro3

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

50 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

IInclusion 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