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Recruiting Observational

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

NCT06805474 · tracked via the Priya Life Science USA tracker
Phase
Observational
Started
2025-01-28
Last updated
2025-03-24

Condition(s) studied

Macular DegenerationGeographic AtrophyStargardt Disease

Investigational drug(s) / intervention(s)

Observational

Observational: Observational

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * 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. Exclusion Criteria: * 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)

Primary outcome measure(s)

  • MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of Stargardt Disease or Geographic Atrophy on MLSDT — 15 days
    Comparison of vision test scores against the ETDRS visual acuity test

Trial sites (1)

FacilityCityRegionStatus
Retina of North Texas, Dallas Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06805474 on ClinicalTrials.gov ↗ ← All trials in the USA