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

Last updated: March 18, 2025
Sponsor: Nanoscope Therapeutics Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Macular Degeneration

Myopic Macular Degeneration

Geographic Atrophy

Treatment

Observational

Clinical Study ID

NCT06805474
NTXOBS-002
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 todemonstrate 3 months of vision stability and be fluid free on OCT.

Exclusion

Exclusion Criteria:

  • Concurrent participation in any interventional clinical trial or receipt of aninvestigational drug within the previous 6 months

  • Presence of any condition other than STGD or GA from AMD on slit lamp exam ordilated 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)

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Observational
Phase:
Study Start date:
January 28, 2025
Estimated Completion Date:
May 27, 2025

Study 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.

Connect with a study center

  • Retina of North Texas,

    Dallas, Texas 75243
    United States

    Active - Recruiting

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