RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-01-28
Study Completion:2025-05-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06805474

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females, age ≥ 18 years
  2. * Able to comprehend and give informed consent.
  3. * Able to comply with testing and all protocol tests.
  4. * Eligible for 1 of 3 cohorts listed below:
  5. * Clinical diagnosis of STGD for cohorts 2 and 3
  6. * Clinical diagnosis for GA (due to AMD) for cohorts 2 and 3
  7. * 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.
  1. * Concurrent participation in any interventional clinical trial or receipt of an investigational drug within the previous 6 months
  2. * 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
  3. * No intra-vitreal injection with anti-VEGF two weeks prior to the study
  4. * Presence of neurological condition that impairs visual acuity
  5. * Individuals who refuse or are incapable of performing the MLSDT of BCVA tests
  6. * Individuals with retinal prosthesis (such as ARGUS-II)

Contacts and Locations

Study Contact

Nozhat Choudry, Ph.D
CONTACT
(817) 857-1186
nchoudry@nanostherapeutics.com

Principal Investigator

Samuel Barone, MD
STUDY_CHAIR
Nanoscope Therapeutics Inc.

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Nanoscope Therapeutics Inc.

  • Samuel Barone, MD, STUDY_CHAIR, 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 Registration Dates

Study Start Date2025-01-28
Study Completion Date2025-05-27

Study Record Updates

Study Start Date2025-01-28
Study Completion Date2025-05-27

Terms related to this study

Keywords Provided by Researchers

  • Multi-Luminance Shape Discrimination Test
  • low-vision magnifying aid (eGlasses)
  • best-corrected visual acuity (BCVA)
  • Early Treatment Diabetic Retinopathy Study ETDRS

Additional Relevant MeSH Terms

  • Macular Degeneration
  • Geographic Atrophy
  • Stargardt Disease