CRYSTALSIGHT: ''Cohort 1.5" Clinical Investigation Study With OCCUTRACK and Tan Tock Seng Eye Clinic to Further Develop Remote Monitoring of Maculopathy at Home Using Artificial Intelligence for Eye Tracking

The development of a next-generation 'CRYSTALSIGHT' solution using combinations of a novel and cost-effective eye-tracking system with artificial intelligence-based eye-tracking algorithms that detect macular abnormalities and enable clinicians to review and monitor the prognosis of patients via a web platform through the following deliverables. 1. Evaluate and improve a home-monitoring regimen involving the self-tests of the CRYSTALSIGHT gaze-tracking system 2. To demonstrate that CRYSTALSIGHT has the same or superior gaze-tracking capacities as Tobii. 3. Evaluate the CRYSTALSIGHT device for its functionality and ease of use as a qualitative measurement tool for patients. 4. Develop the Design History File (DHF) for regulatory filing requirements. 2\. This study will improve on the existing gaze-based scoring methodology for disease activity monitoring over time (delta-change) by quantitatively measuring saccadic speed, pursuit and micro-saccades.

NCT Number	NCT07255885
Lead Sponsor	Tan Tock Seng Hospital Collaborators: Occutrack Medical Solutions Pte Ltd, Agency for Science, Technology and Research, National Healthcare Group, Singapore
Conditions	Maculopathy, Maculopathy, Age Related, Macular Degeneration, Age-Related, Diabetic Retinopathy, Wet Age Related Macular Degeneration, Aged-related Macular Degeneration
Enrollment	20 participants
Start Date	2025-05-08
Primary Completion	2025-05-31 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-01-08