Vision Improvement for Legally Blind Dry AMD Patients

Launched by OPTIMAL ACUITY CORPORATION · May 5, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at a new device that may help improve vision for people who are legally blind due to a condition called dry age-related macular degeneration (dry AMD). The goal is to see if this device can safely help these patients see better. The trial is not yet recruiting participants, but it plans to include men and women aged 50 and older who have dry AMD in one eye and have a specific level of vision impairment.

To be eligible for the study, participants must have a visual acuity (how well they can see) of 20/125 or worse in the study eye, which means they have significant vision loss. They should also have a healthy corneal surface and should not wear contact lenses. Participants will need to commit to regular check-ups and be able to understand and sign a consent form agreeing to join the study. However, people with certain eye conditions, previous eye surgeries, or other health issues that may affect their vision are not eligible. If you or someone you know meets these criteria, this trial may be an exciting opportunity to help improve vision in those affected by dry AMD.

Gender

ALL

Eligibility 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