Status:
NOT_YET_RECRUITING
Vision Improvement for Patients With Age-Related Macular Degeneration
Lead Sponsor:
VIS, Inc.
Conditions:
Macular Degeneration
Eligibility:
All Genders
50-100 years
Phase:
NA
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 dege...
Detailed 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 dege...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06198452
Start Date
January 1 2025
End Date
June 30 2027
Last Update
September 5 2024
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