Assessing a vision test for patients with macular degeneration and Stargardt disease
A Prospective Observational Study to Assess the Reliability and Validity of the Multi-Luminance Shape Discrimination Test (MLSDT) With 9 Objects
Nanoscope Therapeutics Inc. · NCT06805474
This study is testing a new vision test to see how well it works for people with macular degeneration and Stargardt disease compared to standard vision tests.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Nanoscope Therapeutics Inc. (industry) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06805474 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with varying degrees of vision impairment due to STGD or GA, as well as normally sighted individuals for comparison.
Not a fit: Patients with concurrent participation in any interventional studies or those who do not meet the specific visual acuity criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a more reliable method for assessing vision impairment, improving patient management and treatment outcomes.
How similar studies have performed: While this approach is innovative in its specific application, similar studies assessing visual function tests have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Dallas, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Macular Degeneration, Geographic Atrophy, Stargardt Disease, Multi-Luminance Shape Discrimination Test, low-vision magnifying aid, best-corrected visual acuity, Early Treatment Diabetic Retinopathy Study ETDRS