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

March 18, 2025 updated by: Nanoscope Therapeutics Inc.

A Prospective Observational Study to Assess the Reliability and Validity of the Multi-Luminance Shape Discrimination Test (MLSDT) With 9 Objects

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75243
        • Recruiting
        • Retina of North Texas,
        • Contact:
          • Sai H Chavala, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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
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
Observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MLSDT scores in normal and severely visually impaired subjects with a clinical diagnosis of Stargardt Disease or Geographic Atrophy on MLSDT
Time Frame: 15 days
Comparison of vision test scores against the ETDRS visual acuity test
15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanoscope Therapeutics Inc.

Investigators

  • Study Chair: Samuel Barone, MD, Nanoscope Therapeutics Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2025

Primary Completion (Estimated)

May 20, 2025

Study Completion (Estimated)

May 27, 2025

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

January 28, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTXOBS-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The results of the clinical trial will be made available when the study is completed. The results will be published on this site and be available to conference presentations and publications.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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