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

Part of paid clinical trials in Dallas, Texas.

Sponsor
Nanoscope Therapeutics Inc.
Study ID
NCT06805474
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Observational — OTHER
    Observational

Study Details

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 Dates

Start date
Jan 28, 2025
Status verified
Mar 2025
Primary completion
May 20, 2025
Completion
May 27, 2025

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Cohort 1:
    Normal-Sighted Participants with clinically normal ocular findings and BCVA range 20/16 to \<20/40 (ETDRS letter score 71 - 90) in each eye.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of Stargardt Disease or Geographic Atrophy on MLSDT [ Time Frame: 15 days ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Retina of North Texas,DallasTexas75243
Sai H Chavala, MD

Find similar trials in Dallas, TX

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retina of North Texas· Dallas, TX

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