A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT

Recruiting now

Conditions studied: Macular Degeneration, Geographic Atrophy, Stargardt Disease

In brief

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.

Key facts

Study ID

NCT06805474

Run by

Nanoscope Therapeutics Inc.

People needed

30

Starts

2025-01-28

Expected to finish

2025-05-27

Last updated by the study team

2025-03-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and females, age ≥ 18 years
• Able to comprehend and give informed consent.
• Able to comply with testing and all protocol tests.
• Eligible for 1 of 3 cohorts listed below:
• Cohort 1: Normal-Sighted Participants with clinically normal ocular findings and BCVA range 20/16 to <20/40 in each eye (ETDRS letter score 71 - 90) Cohort 2: Moderately-Sight Impaired Participants with a BCVA range of 20/40 to <20/200 (ETDRS letter score of 36 - 70) and a clinical diagnosis of STGD/GA Cohort 3: Severely-Sight Impaired Participants with a BCVA range of 20/200 to 20/800 (ETDRS letter score of 5 - 35) and a clinical diagnosis of advanced STGD/GA
• Clinical diagnosis of STGD for cohorts 2 and 3
• Clinical diagnosis for GA (due to AMD) for cohorts 2 and 3
• Participants who have had anti-VEGF therapy 2 weeks prior to enrollment have to demonstrate 3 months of vision stability and be fluid free on OCT.

You may not qualify if…

• Concurrent participation in any interventional clinical trial or receipt of an investigational drug within the previous 6 months
• Presence of any condition other than STGD or GA from AMD on slit lamp exam or dilated ophthalmoscopy that impairs visual acuity or visual fields e.g., corneal opacity, visually significant cataract or visual field loss in glaucoma
• No intra-vitreal injection with anti-VEGF two weeks prior to the study
• Presence of neurological condition that impairs visual acuity
• Individuals who refuse or are incapable of performing the MLSDT of BCVA tests
• Individuals with retinal prosthesis (such as ARGUS-II)

Where it is running

• Retina of North Texas, — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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