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

NCT06805474 | Recruiting

• 1 other identifier: NTXOBS-002
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

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

  15 days

Study Arms (3)

Cohort 1:

Normal-Sighted Participants with clinically normal ocular findings and BCVA range 20/16 to \<20/40 (ETDRS letter score 71 - 90) in each eye.

Other: Observational

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.

Other: Observational

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.

Other: Observational

Interventions

Observational OTHER

Observational

Cohort 1:; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Nanoscope Therapeutics Inc.: lead

Study Sites (1)

Retina of North Texas,

Dallas, Texas, 75243, United States

RECRUITING

MeSH Terms

Conditions

Macular Degeneration; Geographic Atrophy; Stargardt Disease

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Eye Diseases, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Samuel Barone, MD

  Nanoscope Therapeutics Inc.

  STUDY CHAIR

Central Study Contacts

Nozhat Choudry, Ph.D

CONTACT

(817) 857-1186; nchoudry@nanostherapeutics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: January 28, 2025
• Primary Completion: May 20, 2025
• Study Completion: May 27, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

US (1)