Actively Recruiting
A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT
Led by Nanoscope Therapeutics Inc. · Updated on 2025-03-24
30
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this observational study is to assess the reliability and validity of the 9-object MLSDT for evaluation of participants with moderate to severe vision impairment when tested without a wearable low-vision magnifying aid (eGlasses) and then with eGlasses. These results will be compared to ETDRS testing results for the same participants without eGlasses and then with eGlasses. Two cohorts will consist of participants who have vision loss due to STGD or geographic atrophy (GA) due to age-related macular degenerations (AMD). Normally sighted participants will provide a control group.
CONDITIONS
Official Title
A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females, age 63 18 years
- Able to understand and give informed consent
- Able to complete all study tests
- Eligible for one of three groups: normal sight (BCVA 20/16 to <20/40), moderate impairment (BCVA 20/40 to <20/200) with STGD or GA, or severe impairment (BCVA 20/200 to 20/800) with advanced STGD or GA
- Clinical diagnosis of Stargardt Disease for moderate and severe groups
- Clinical diagnosis of geographic atrophy due to AMD for moderate and severe groups
- Those who had anti-VEGF therapy within 2 weeks prior to enrollment must show 3 months of stable vision and be fluid free on OCT
You will not qualify if you...
- Participation in another interventional trial or use of investigational drug within last 6 months
- Any eye condition other than STGD or GA that affects vision, such as corneal opacity, significant cataract, or glaucoma
- No anti-VEGF injections within 2 weeks before the study
- Neurological conditions that reduce visual acuity
- Unable or unwilling to perform MLSDT or BCVA tests
- Presence of retinal prosthesis such as ARGUS-II
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Retina of North Texas,
Dallas, Texas, United States, 75243
Actively Recruiting
Research Team
N
Nozhat Choudry, Ph.D
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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