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

Description

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
Macular Degeneration
Intervention / Treatment

-

Contacts and Locations

Dallas

Retina of North Texas,, Dallas, Texas, United States, 75243

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • * 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.
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Nanoscope Therapeutics Inc.,

Samuel Barone, MD, STUDY_CHAIR, Nanoscope Therapeutics Inc.

Study Record Dates

2025-05-27