Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06805474

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

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Retina of North Texas,

Dallas, Texas, United States, 75243

Actively Recruiting

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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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