Vision Improvement for Patients With Age-Related Macular Degeneration

VIS, Inc.

Status: Not yet enrolling

Conditions: Macular Degeneration

Treatments: Procedure: Vision Improvement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06198452

VIS #001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 50 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Vision Improvement

Experimental group

Treatment:

Procedure: Vision Improvement