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

January 5, 2026 updated by: Laude Augustinus, Tan Tock Seng Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Macula degeneration is more prevalent with ageing and can result in blurred or distorted vision, often accompanied by a dark patch blocking the center of the visual field. In the management of age-related macular degeneration (AMD), patients are required to attend regular check-ups at the specialist eye clinic by the clinician to monitor if their disease. The eye examinations that patients undergo during these clinic visits which may include fundoscopy and optical coherence tomography. A preventive treatment for exudative or wet AMD is the administration of an intravitreal injection of an anti-vascular endothelial growth factor (anti-VEGF) at these regular clinic sessions.

Although anti-vascular endothelial growth factor (VEGF) injections are an effective treatment for many patients with Wet-AMD, there are several unmet needs in treatment of AMD and none of them cures the disease or reverses its course. Some patients do not respond to VEGF injections. There are no standardized treatment schedules, there is a large treatment burden, and visual loss continues over time.

Additionally, the main drawback of anti-VEGF therapy is its high cost, which suppose a significant burden on health systems, and often makes such a regimen unaffordable in clinical practice. There is no treatment for GA. Therefore, the prevention of advanced disease like Wet-AMD and finding new and effective treatments remain a significant challenge. Advances in imaging and genetics and molecular technologies have led to the identification of new risk factors for disease progression, but not all have been evaluated in comprehensive prediction models. Perhaps, comprehensive prediction models could lead to the development of tailored, individualized therapy and improve the personalised healthcare.

As such, the application of this next-generation OCCUTRACK Technology to develop a comprehensive risk score algorithm and to estimate the risk scores to identify individuals at high risk for disease progression to advanced stages would result in earlier intervention and reduced burden of visual loss due to AMD. This approach could enable the tailored individualized Anti-VEGF Therapy to promote personalized medicine and improve the quality of life of patients with Wet-AMD.

A Proof-of-Concept (POC) was completed by TTSH clinician and AStar-I2R scientist to co-develop and patent a software - Automated Vision Assessment and Impairment Detection through Gaze Analysis (AVIGA). AVIGA is now referred to as "CRYSTALSIGHT" as part of the commercialization branding. A local medical incubator, Trendlines Medical Singapore, has licensed it from the research party. This led to the spin-off of a new company - Occutrack Pte Ltd to continue the collaboration with TTSH, focusing on the commercialization of the CRYSTALSIGHT. AVIGA previously used a costly commercial tobii gaze tracker that could potentially limit consumer adoption, the CRYSTALSIGHT system was designed to mitigate costs by incorporating an AI-augmented video camera with gaze tracking algorithms designed to provide a comprehensive assessment of a patient's vision. With this non-invasive technology, retinal specialists can monitor the real time progression and prognosis of patients with AMD while they are in the comfort of their own home without the need for manual or skilled intervention and expensive equipment.

This project proposal is to evaluate the performance and accuracy of the CRYSTALSIGHT technology as a tool for determining macular disease activity.

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult individuals will be voluntarily recruited from Tan Tock Seng Hospital (TTSH) Ophthalmology Specialist Outpatient Clinics after they have been assessed for eligibility based on established clinical diagnosis from the case notes through TTSH NGEMR. Informed consent will be obtained for participation in this study.

Description

Inclusion Criteria:

  1. Participants between ages 21 and 100
  2. Both genders
  3. Subjects with maculopathies
  4. Ability to comply with the study protocol, in the investigator's judgment
  5. Subjects must have the cognitive capacity to provide personal consent (i.e. no cognitively impaired persons will be recruited).

Exclusion Criteria:

  1. 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.
  2. 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.
  3. History of idiopathic or autoimmune-associated uveitis in either eye.
  4. Active ocular inflammation or suspected or active ocular or periocular infection in either eye.
  5. Other protocol-specified exclusion criteria may apply.
  6. Individuals with indications of cognitive impairment and unable to make decisions for themselves to provide informed consent will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CRYSTALSIGHT
Presenting stimulus targets while using Crystalsight: The test presents three types of targets and assesses corresponding gaze responses in pseudorandom succession on the screen. During this, the Crystalsight AI uses a high-definition camera to perform eye-gaze tracking to generate data coordinates of eye movement.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement of CRYSTALSIGHT with Tobii Gaze Tracker for Macular Disease Monitoring
Time Frame: Baseline
To assess the agreement between the CRYSTALSIGHT device and the commercial Tobii eye tracker in quantifying gaze parameters (e.g., saccadic velocity, pursuit stability, micro-saccades) in patients with maculopathies.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agnostic Concordance of CRYSTALSIGHT with Clinical Disease Activity
Time Frame: Baseline
To assess whether CRYSTALSIGHT-generated scores correspond with disease activity levels as determined by standard clinical evaluations (e.g., OCT imaging, clinical diagnosis).
Baseline
Rate of Incomplete or Failed Tests Using CRYSTALSIGHT
Time Frame: Baseline
To determine the operational reliability of CRYSTALSIGHT by measuring the frequency of unsuccessful or incomplete tests due to user or device limitations.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Collaborators

National Healthcare Group, Singapore
Agency for Science, Technology and Research
Occutrack Medical Solutions Pte Ltd

Investigators

  • Principal Investigator: Augustinus Laude, MBChB, Tan Tock Seng Hospital
  • Study Director: Zheng Kuang Noel Soh, BSc, Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2025

Primary Completion (Actual)

May 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Estimated)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-3478

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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