Vision Improvement for Patients With Age-Related Macular Degeneration

Launched by VIS, INC. · Jan 8, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new device called the Opti-K Low Vision Aid, designed to help improve vision for people suffering from age-related macular degeneration (AMD). AMD is a condition that affects the central part of the retina, leading to vision loss. The study aims to determine how safe and effective this device is for patients with advanced stages of AMD.

To participate, you must be at least 50 years old and have been diagnosed with either dry or wet AMD in one or both eyes. You should also have significant vision impairment, meaning your best-corrected eyesight is 20/80 or worse in your better eye. However, if you have certain eye conditions, such as corneal disease or have had previous eye surgeries, you may not be eligible. Participants will undergo various examinations, and it's important that you can commit to these appointments. The trial is not yet recruiting, but if you're interested, it could be an opportunity to explore potential vision improvement options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects who meet all of the following criteria are candidates for this study:
• • 1. Male or Female
• • 2. Any race
• • 3. Patient is at least 50 years old.
• • 4. Patient has diagnosed end stage dry or wet age-related macular degeneration in one or both eyes, as verified by a complete ocular examination.
• • 5. Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
• • 6. Patient has manifest refraction, spherical equivalent (MRSE) between -1.50 D to 1.50 D in eye(s) to be treated.
• • 7. Patient has moderate to severe vision impairment due to age-related macular degeneration with best spectacle-corrected distance visual acuity (CDVA) of 20/80 or worse (decimal less than or equal to 0.25; logMAR ≥ 0.60).in the better eye.
• • 8. Patient has CDVA of 20/400 or better (decimal greater than or equal to 0.05; logMAR ≤ 1.30) in the worse eye.
• • 9. Patient is not a contact lens (CL) wearer.
• • 10. Patient is willing and able to comply with all examinations.
• • 11. Patient must be competent to sign an informed consent form before study entry.
• Exclusion Criteria:
• Subjects who meet any of the following criteria are to be excluded from this study:
• • 1. Corneal disease or corneal disorder in either eye.
• • 2. Pathological retinal morphology in either eye that completely affects the entire 10° (3 mm diameter) of the retina centered on the foveola.
• • 3. Gonzalez-Markowitz chart Potential Visual Acuity (PVA) in the eye to be treated that is not improved by at least four lines compared to CDVA;
• • 4. Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma;
• • 5. Previous corneal surgery in the eye to be treated; and
• • 6. 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 that may confound the outcome of the study.