Observational Study of MLSDT for Macular Degeneration and Stargardt Disease

This observational study is looking at how well a vision test called the MLSDT works for people with vision loss from Stargardt Disease or geographic atrophy (a type of age-related macular degeneration). Researchers want to see if the MLSDT, which uses 9 shapes, is a reliable and accurate way to measure functional vision, both with and without special magnifying glasses (eGlasses). They will compare these results to another common vision test called ETDRS. The study aims to enroll 30 participants, including those with normal vision and those with moderate to severe vision impairment. The main goal is to see how MLSDT scores compare between these groups after 15 days.

Study design
This is an observational study involving 30 participants, divided into different groups based on their vision. It is not a randomized or blinded study.
What's involved
Participants will undergo MLSDT testing both with and without eGlasses, and ETDRS testing both with and without eGlasses. The primary endpoint is measured at 15 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 15 days, indicating a short follow-up period.

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NCT06805474

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

Recruiting
Not specifiedAges 18+Observational
Nanoscope Therapeutics Inc.
~30 participants
Updated 2025-03-24 on ClinicalTrials.gov
What's tested:Observational

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of Stargardt Disease or Geographic Atrophy on MLSDT
Measured over 15 days
Macular Degeneration
Geographic Atrophy
Stargardt Disease
1 sites across 1 states
Texas1
  • Samuel Barone, MD · STUDY_CHAIR · Nanoscope Therapeutics Inc.

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Eligibility criteria

Inclusion

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:
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

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)
  • MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of Stargardt Disease or Geographic Atrophy on MLSDT15 days

    Comparison of vision test scores against the ETDRS visual acuity test