Vision Improvement for Patients With Age-Related Macular Degeneration

NCT06198452 | Not Yet Recruiting DMC

• 1 other identifier: VIS #001
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Visual Acuity

  Standard measurements of visual acuity before and after treatment

  1 year

Study Arms (1)

Vision Improvement

EXPERIMENTAL

Procedure: Vision Improvement

Interventions

Vision Improvement PROCEDURE

Laser Vision Improvement for Patients with Age-Related Macular Degeneration

Vision Improvement

Eligibility Criteria

• Age: 50 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VIS, Inc.: lead

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Michael Berry, PhD

CONTACT

8318691384; mberry177@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective cohort study

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: January 10, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 5, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share