A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT

Launched by NANOSCOPE THERAPEUTICS INC. · Jan 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new way to evaluate vision in people with certain eye conditions, specifically macular degeneration, geographic atrophy, and Stargardt disease. The researchers want to see how reliable and valid a specific test called the MLSDT is for assessing vision impairment. Participants will be tested both without and with special glasses designed to help them see better. The results from this test will be compared to another established vision test to ensure accuracy.

To join the study, individuals must be at least 18 years old and able to understand and consent to the testing. There are three groups of participants: those with normal vision, those with moderate vision impairment, and those with severe vision impairment due to the specified eye conditions. Participants can expect to undergo several vision tests, and the study is currently recruiting individuals who meet the eligibility criteria. It’s important to know that those recently involved in other clinical trials or with certain eye conditions may not qualify.

Gender

ALL

Eligibility 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)