NCT07255859

CRYSTALSIGHT Cohort 2.0

CRYSTALSIGHT: Clinical Evaluation of OCCUTRACK's CRYSTALSIGHT Device Through Remote Monitoring for Disease Recurrence of Wet Aged-Related Macular Degeneration Using Eye Gaze Tracking (Cohort 2.0).

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Tan Tock Seng Hospital · Academic / Other
• Sex: All
• Age: 55 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

Age-Macular Degeneration (AMD) is a common eye condition and a leading cause of vision loss among people age 50 and older. It causes damage to the macula, a small area near the centre of the retina needed for sharp, central vision. It is estimated that the prevalence of early and late AMD in Asian populations aged 40 to 79 were 6.8% and 0.56% respectively. Prevalence in white populations estimated from large population studies were 8.8% and 0.59% respectively. With the aging population and people living longer, these numbers will only increase. Hence, this study aims to develop a system to evaluate OCCUTRACK's CRYSTALSIGHT device through remote monitoring for disease recurrence of wet aged-related macular degeneration using eye gaze tracking.

Detailed description

Age-Related Macular Degeneration (AMD) and Diabetic macular Edema (DME) is one of the main causes of central vision loss. Most patients require pharmacologic treatment with anti-vascular endothelial growth factor (VEGF) agents with multiple follow-up visits that include optical coherence tomography (OCT), visual acuity testing and multiple injections. The high frequency of visits puts pressure on eye clinics and can be extremely stressful for both patients and their caregivers. Therefore, portable and rapidly deployable self-administered home-based examination devices are key to making telemedicine a reality. OCCUTRACK Medical Solutions has developed a portable, self-administered device designed for gaze-tracking and monitoring of patients with retinal diseases such as AMD and DME, and choroidal neovascularization (CNV) that require multiple anti-VEGF injections. The team have confirmed the performance of the CRYSTALSIGHT device and validated the retinal thickness measurements obtained with this device by comparing it to in-hospital Optical Coherence Tomography (OCT) (Heidelberg Spectralis). In this study, the team will conduct a randomized clinical trial RCT to compare the efficacy and cost-effectiveness of a Pro Re Nana (PRN) management regimen enhanced with the CRYSTALSIGHT home monitoring device for the detection of central metamorphopsia with existing PRN standard of care for patients with AMD or DME exiting the anti-VEGF injection regimen.

Conditions

• Maculopathy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Amsler Grid	The Amsler grid is a tool used to monitor the macula, the central part of the retina, for changes in vision that can be indicative of various eye conditions, particularly age-related macular degeneration (AMD). It helps detect and monitor metamorphopsia (distorted vision) or scotoma (blind spots) in the central visual field.
DEVICE	CRYSTALSIGHT	OCCUTRACK's CRYSTALSIGHT device tracks these eye movements with generated patterns on the screen, a visual assessment of affected and unaffected eyes is achieved without expensive optics and at home on any tablet or laptop computer. CRYSTALSIGHT is a home-based gaze-tracking readily available for home hyperacuity monitoring for these and other high-risk eyes with diagnosed wet-AMD.

Timeline

• Start date: 2025-06-16
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2025-12-01
• Last updated: 2026-01-08

Locations

1 site across 1 country: Singapore