Clinical trial NCT06805474: A Prospective Observational Study to Assess the Reliability and Validity of the MLSDT
Official title: A Prospective Observational Study to Assess the Reliability and Validity of the Multi-Luminance Shape Discrimination Test (MLSDT) With 9 Objects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Macular Degeneration
Geographic Atrophy
Stargardt Disease
Keywords: Multi-Luminance Shape Discrimination Test
low-vision magnifying aid (eGlasses)
best-corrected visual acuity (BCVA)
Early Treatment Diabetic Retinopathy Study ETDRS
Lead sponsor: Nanoscope Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: Here, we aim to test the accuracy and validate the MLSDT using 9 shapes (instead of 3 shapes) as a reliable, standardized and efficient test of functional vision in STGD and GA patients with impaired vision. This includes evaluation of the performance (retest variability and repeatability) of the test(s) based on patients' visual acuity. Furthermore, we will explore descriptive relationships between MLSDT with best-corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study ETDRS) eye chart.

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)

Primary outcomes:
measure: MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of Stargardt Disease or Geographic Atrophy on MLSDT
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Retina of North Texas,
state: Texas
Study officials:
affiliation: Nanoscope Therapeutics Inc.
name: Samuel Barone, MD
role: STUDY_CHAIR
References: