Vision Improvement for Patients With Age-Related Macular Degeneration

This study is being conducted to assess the safety and efficacy of the VIS, LLC (VIS) Opti-K Low Vision Aid Device and treatment to provide vision improvement to patients with age-related macular degeneration.

Inclusion criteria

Subjects who meet all of the following criteria are candidates for this study:

• Male or Female
• Any race
• Patient is at least 50 years old.
• Patient has diagnosed end stage dry or wet age-related macular degeneration in one or both eyes, as verified by a complete ocular examination.
• Patient is pseudophakic or is phakic with no clinically significant cataract in eye(s) to be treated.
• Patient has manifest refraction, spherical equivalent (MRSE) between -1.50 D to 1.50 D in eye(s) to be treated.
• 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.
• Patient has CDVA of 20/400 or better (decimal greater than or equal to 0.05; logMAR ≤ 1.30) in the worse eye.
• Patient is not a contact lens (CL) 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

Subjects who meet any of the following criteria are to be excluded from this study:

• Corneal disease or corneal disorder in either eye.
• Pathological retinal morphology in either eye that completely affects the entire 10° (3 mm diameter) of the retina centered on the foveola.
• 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;
• Increased IOP (above 20 mm Hg), glaucoma or history of glaucoma;
• Previous corneal surgery in the eye to be treated; and
• 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.