NCT06805474 · Nanoscope Therapeutics Inc.
A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT
What this study 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.
View original scientific description
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.
Interventions
OTHER
Observational
Observational
Primary outcome measures
MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of Stargardt Disease or Geographic Atrophy on MLSDT
Time frame: 15 days
Comparison of vision test scores against the ETDRS visual acuity test
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 24, 2025 · Source of record for eligibility and locations