CRYSTALSIGHT: ''Cohort 1.5" Clinical Investigation Study With OCCUTRACK and Tan Tock Seng Eye Cli… (NCT07255885) | Clinical Trial Compass
CompletedNot Applicable
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
Singapore20 participantsStarted 2025-05-08
Plain-language summary
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.
Who can participate
Age range21 Years – 100 Years
SexALL
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Inclusion criteria
✓. Participants between ages 21 and 100
✓. Both genders
✓. Subjects with maculopathies
✓. Ability to comply with the study protocol, in the investigator's judgment
✓. Subjects must have the cognitive capacity to provide personal consent (i.e. no cognitively impaired persons will be recruited).
Exclusion criteria
✕. Uncontrolled blood pressure, defined as systolic blood pressure \>180 millimeters of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg while a patient is at rest.
✕. Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study.
✕. History of idiopathic or autoimmune-associated uveitis in either eye.
✕. Active ocular inflammation or suspected or active ocular or periocular infection in either eye.
What they're measuring
1
Agreement of CRYSTALSIGHT with Tobii Gaze Tracker for Macular Disease Monitoring
✕. Other protocol-specified exclusion criteria may apply.
✕. Individuals with indications of cognitive impairment and unable to make decisions for themselves to provide informed consent will be excluded from the study.