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

NCT07255885 | Completed

• 1 other identifier: 2024-3478
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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. 1.Evaluate and improve a home-monitoring regimen involving the self-tests of the CRYSTALSIGHT gaze-tracking system
2. 2.To demonstrate that CRYSTALSIGHT has the same or superior gaze-tracking capacities as Tobii.
3. 3.Evaluate the CRYSTALSIGHT device for its functionality and ease of use as a qualitative measurement tool for patients.
4. 4.Develop the Design History File (DHF) for regulatory filing requirements.

Conditions

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

Keywords

gaze-tracking

Outcome Measures

Primary Outcomes (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.

  Baseline

Secondary Outcomes (2)

• Agnostic Concordance of CRYSTALSIGHT with Clinical Disease Activity

  Baseline

• Rate of Incomplete or Failed Tests Using CRYSTALSIGHT

  Baseline

Study Arms (1)

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

Interventions

CRYSTALSIGHT Test DEVICE

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.

CRYSTALSIGHT

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Individuals with indications of cognitive impairment and unable to make decisions for themselves to provide informed consent will be excluded from the study.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• Occutrack Medical Solutions Pte Ltd: collaborator
• Agency for Science, Technology and Research: collaborator
• National Healthcare Group, Singapore: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Related Publications (12)

• 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.

  PMID: 18439679 BACKGROUND

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

  PMID: 18577497 BACKGROUND

• 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.

  PMID: 29060394 BACKGROUND

• 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.

  PMID: 22173073 BACKGROUND

• 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.

  PMID: 24211172 BACKGROUND

• 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.

  PMID: 22840421 BACKGROUND

• 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.

  PMID: 24385141 BACKGROUND

• 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.

  PMID: 10588299 BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 29060564 BACKGROUND

• 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.

  PMID: 28268575 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Augustinus Laude, MBChB

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

• Zheng Kuang Noel Soh, BSc

  Tan Tock Seng Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: December 1, 2025
• Study Start: May 8, 2025
• Primary Completion: May 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)