Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2026-01-01 @ 9:38 PM
Study NCT ID:
NCT07255859
Status:
RECRUITING
Last Update Posted:
2025-12-01
First Post:
2025-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CRYSTALSIGHT Cohort 2.0
Sponsor:
Tan Tock Seng Hospital
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: