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
Qualifiers
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 design
Treatments tested in this trial
- Observational
Treatment groups
30 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov