NCT06805474Recruiting
A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT
A Prospective Observational Study to Assess the Reliability and Validity of the Multi-Luminance Shape Discrimination Test (MLSDT) With 9 Objects
Source: ClinicalTrials.gov · Last updated 24 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 28 Jan 2025
- Start date
- 28 Jan 2025
- Primary completion date
- 20 May 2025
- Lead sponsor
- Nanoscope Therapeutics Inc.
- Diseases
- Macular degeneration, Diabetic eye disease
- NCT number
- NCT06805474
What you commit to
- Study type: Observational
- Planned participants: 30
- From 28 Jan 2025 to the primary completion date, 20 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Retina of North Texas Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.