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

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.

Conditions

• Maculopathy
• Maculopathy, Age Related
• Macular Degeneration, Age-Related
• Diabetic Retinopathy
• Wet Age Related Macular Degeneration
• Aged-related Macular Degeneration

Interventions

DEVICE

CRYSTALSIGHT Test

Eye gaze tracking tests will be automated, and patients will only need to follow through with the stimulus/image shown without physical contact with the eye gaze tracker using CRYSTALSIGHT and Tobii. A series of stimulus dots in the form of a pursuit (moving stimulus) or saccade (fixed stimulus and fixed speed) will be presented on the screen and the user under test (UAT) will need to look at the targets presented. The test is similar to Microperimetry and Humphrey's visual field test. A score will be generated at the end of the test. Research Procedure: 1. CRYSTALSIGHT 2. Tobii Subjects perform the CRYSTALSIGHT test monocularly and pursue a pre-determined target moving in a customized waveform across the computer screen. The trail of the gaze points generated by the subject following the target is simultaneously recorded and stored. Eye dilation will not be required for the purpose of this research study as fundoscopy nor OCT imaging will not be performed.

Sponsors & Collaborators

• Occutrack Medical Solutions Pte Ltd

  collaborator UNKNOWN

• Agency for Science, Technology and Research

  collaborator OTHER

• National Healthcare Group, Singapore

  collaborator OTHER_GOV

• Tan Tock Seng Hospital

  lead OTHER

Principal Investigators

• Augustinus Laude, MBChB · Tan Tock Seng Hospital

• Zheng Kuang Noel Soh, BSc · Tan Tock Seng Hospital

Eligibility

Min Age

21 Years

Max Age

100 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-08

Primary Completion

2025-05-31

Completion

2025-12-31

Countries

• Singapore

Study Locations