A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNanoscope Therapeutics Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Males and females, age ≥ 18 years
Able to comprehend and give informed consent.
Able to comply with testing and all protocol tests.
Clinical diagnosis of STGD for cohorts 2 and 3
Disqualifiers
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
Trial population
This study will enroll approximately 30 adult participants, to one of 3 cohorts. Participants who meet all the inclusion criteria and for whom none of the exclusion criteria apply will be eligible for enrollment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational
Other interventionObservational
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Cohort 1:1 intervention
Group B: Cohort 21 intervention
Group C: Cohort 31 intervention
Trial outcomes
Primary outcomes
1
MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of Stargardt Disease or Geographic Atrophy on MLSDT
Comparison of vision test scores against the ETDRS visual acuity test
Time frame
15 daysSponsors and contacts
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Source ClinicalTrials.gov