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

What this Trial Is About

Researchers are evaluating the accuracy and reliability of the Multi-Luminance Shape Discrimination Test (MLSDT) with 9 objects in people with moderate to severe vision impairment. The study focuses on participants diagnosed with Stargardt Disease (STGD) or Geographic Atrophy (GA) caused by age-related macular degeneration (AMD). The goal is to compare MLSDT results with standard visual acuity measurements using the Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart and to assess how well the test measures functional vision across different levels of vision loss. Participants are divided into three groups: those with normal vision, moderately impaired vision, and severely impaired vision, based on their best-corrected visual acuity (BCVA) scores and clinical diagnosis. The study involves testing each participant's vision using the MLSDT without and then with the use of a wearable low-vision magnifying device called eGlasses. Their performance on the MLSDT will be compared to ETDRS test results under the same conditions. During the study, participants will undergo vision tests with and without eGlasses, and their visual acuity will be measured using the ETDRS chart. Researchers will evaluate the test's repeatability and variability, along with relationships between MLSDT scores and BCVA. The primary outcome is the MLSDT score in normal and severely visually impaired participants with STGD or GA, assessed within 15 days. Participants' ability to complete the tests and maintain vision stability will be monitored throughout the study period.

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