NCT06805474

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 30 (estimated)
• Sponsor: Nanoscope Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Macular Degeneration
• Geographic Atrophy
• Stargardt Disease

Interventions

Type	Name	Description
OTHER	Observational	Observational

Timeline

• Start date: 2025-01-28
• Primary completion: 2025-05-20
• Completion: 2025-05-27
• First posted: 2025-02-03
• Last updated: 2025-03-24

Locations

1 site across 1 country: United States