Dry Age-related Macular Degeneration, Vision Impairment and Blindness
Conditions
Keywords
AMD, vision impairment, blindness
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.
Interventions
DEVICEClear-K Low Vision Aid Treatment
A Clear-K Low Vision Aid Device is used to produce small corneal shape and refraction changes in order to redirect light onto functional areas of the retina.
Sponsors
Optimal Acuity Corporation
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best spectacle-corrected distance visual acuity (BCDVA) | 12 months post-treatment | BCDVA measured using ETDRS eye charts |
Contacts
Primary ContactMichael Berry, PhD
Outcome results
None listed