Assessing a vision test for patients with macular degeneration and Stargardt disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the reliability and validity of the Multi-Luminance Shape Discrimination Test (MLSDT) in participants with moderate to severe vision impairment, specifically those with Stargardt Disease (STGD) and geographic atrophy (GA). Participants will be tested both with and without a low-vision magnifying aid (eGlasses), and results will be compared to the Early Treatment Diabetic Retinopathy Study (ETDRS) testing outcomes. The study will include two cohorts of impaired vision patients and a control group of normally sighted individuals to assess the performance and repeatability of the MLSDT. The goal is to establish a standardized method for evaluating functional vision in these patient populations.

Why it matters

Who can join: the full rules

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)

Where it's running

• Retina of North Texas,
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Nozhat Choudry, Ph.D
• Email: nchoudry@nanostherapeutics.com
• Phone: (817) 857-1186

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.