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MaculopathyNCT07255885

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

An observational study of Maculopathy and Maculopathy, Age Related, run by Tan Tock Seng Hospital at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 100 years
What is being tested?
CRYSTALSIGHT Test
Type of treatment
Medical device
How many people
20 participants
Where
1 siteSingapore
Study dates
8 May 2025to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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).

Who cannot join

  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

About this study

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.
  5. 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.
Read the 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.

Being tested
CRYSTALSIGHT Test
Keywords
gaze-tracking
Medical subject headings
Macular Degeneration, Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CRYSTALSIGHT TestDevice

    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.

Study groups in NCT07255885
Study groupRoleWhat they receive
CRYSTALSIGHTPresenting 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.
Receives: Device: CRYSTALSIGHT Test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Agreement of CRYSTALSIGHT with Tobii Gaze Tracker for Macular Disease Monitoring

    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.

    Measured: Baseline

Secondary outcomes (2)

  1. Agnostic Concordance of CRYSTALSIGHT with Clinical Disease Activity

    To assess whether CRYSTALSIGHT-generated scores correspond with disease activity levels as determined by standard clinical evaluations (e.g., OCT imaging, clinical diagnosis).

    Measured: Baseline

  2. Rate of Incomplete or Failed Tests Using CRYSTALSIGHT

    To determine the operational reliability of CRYSTALSIGHT by measuring the frequency of unsuccessful or incomplete tests due to user or device limitations.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2025
  2. Study start8 May 2025
  3. Primary completion31 May 2025
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07255885
Sponsor's protocol ID
2024-3478
Status last verified
Jan 2026
First submitted
17 Mar 2025
Last updated
8 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kawasaki R, Wang JJ, Aung T, Tan DT, Mitchell P, Sandar M, Saw SM, Wong TY; Singapore Malay Eye Study Group. Prevalence of age-related macular degeneration in a Malay population: the Singapore Malay Eye Study. Ophthalmology. 2008 Oct;115(10):1735-41. doi: 10.1016/j.ophtha.2008.02.012. Epub 2008 Apr 25.

    PubMed 18439679

  • Trevino R, Kynn MG. Macular function surveillance revisited. Optometry. 2008 Jul;79(7):397-403. doi: 10.1016/j.optm.2007.09.017.

    PubMed 18577497

  • Ai Ping Yow, Damon Wong, Huiying Liu, Hongyuan Zhu, Ivy Jing-Wen Ong, Laude A, Tock Han Lim. Automatic visual impairment detection system for age-related eye diseases through gaze analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:2450-2453. doi: 10.1109/EMBC.2017.8037352.

    PubMed 29060394

  • Mathew R, Sivaprasad S. Environmental Amsler test as a monitoring tool for retreatment with ranibizumab for neovascular age-related macular degeneration. Eye (Lond). 2012 Mar;26(3):389-93. doi: 10.1038/eye.2011.326. Epub 2011 Dec 16.

    PubMed 22173073

  • AREDS2-HOME Study Research Group; Chew EY, Clemons TE, Bressler SB, Elman MJ, Danis RP, Domalpally A, Heier JS, Kim JE, Garfinkel R. Randomized trial of a home monitoring system for early detection of choroidal neovascularization home monitoring of the Eye (HOME) study. Ophthalmology. 2014 Feb;121(2):535-44. doi: 10.1016/j.ophtha.2013.10.027. Epub 2013 Nov 8.

    PubMed 24211172

  • AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.

    PubMed 22840421

  • Chew EY, Clemons TE, Agron E, Sperduto RD, Sangiovanni JP, Davis MD, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Ten-year follow-up of age-related macular degeneration in the age-related eye disease study: AREDS report no. 36. JAMA Ophthalmol. 2014 Mar;132(3):272-7. doi: 10.1001/jamaophthalmol.2013.6636.

    PubMed 24385141

  • Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study (AREDS): design implications. AREDS report no. 1. Control Clin Trials. 1999 Dec;20(6):573-600. doi: 10.1016/s0197-2456(99)00031-8.

    PubMed 10588299

  • Goldberg, J.H. and A.M. Wichansky, Eye tracking in usability evaluation: A practitioner's guide, in the Mind's Eye. 2003, Elsevier. p. 493-51

  • Goldberg, J.H. and X.P. Kotval, Computer interface evaluation using eye movements: methods and constructs. International journal of industrial ergonomics, 1999. 24(6): p. 631

  • Huiying Liu, Yanwu Xu, Damon Wong, Ai Ping Yow, Laude A, Tock Han Lim. Detecting impaired vision caused by AMD from gaze data. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:3142-3145. doi: 10.1109/EMBC.2017.8037523.

    PubMed 29060564

  • Huiying Liu, Wong D, Ai Ping Yow, Yanwu Xu, Fengshou Yin, Laude A, Tock Han Lim. Determining the difference in eyegaze measurements in individuals with age related macular degeneration. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:1348-1351. doi: 10.1109/EMBC.2016.7590957.

    PubMed 28268575

Questions about this trial

What is this clinical trial studying?

An observational study of Maculopathy and Maculopathy, Age Related, run by Tan Tock Seng Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Agreement of CRYSTALSIGHT with Tobii Gaze Tracker for Macular Disease Monitoring (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07255885, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.

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