CRYSTALSIGHT Cohort 2.0

NCT07255859 | Recruiting

• 1 other identifier: 2024-3705
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Maculopathy

Keywords

aged-related macular degeneration; diabetic macular edema; diabetic retinopathy; choroidal neovascularization; wet aged-related macular degeneration; gaze tracking; dry aged-related macular degeneration; maculopathy

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy Using One-Sided Confidence Interval or One-Sided Hypothesis Test

  To assess whether the CRYSTALSIGHT device is non-inferior to the standard of care (Amsler grid) in detecting recurrence of wet-AMD during patient recall, by comparing both generated scores, validated by OCT readings.

  12 Months

Secondary Outcomes (2)

• Correlation with Optical Coherence Tomography (OCT)

  12 Months

• User Experience & Functionality

  12 Months

Study Arms (2)

Amsler Grid

ACTIVE COMPARATOR

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.

Diagnostic Test: Amsler Grid

CRYSTALSIGHT Arm

EXPERIMENTAL

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.

Device: CRYSTALSIGHT

Interventions

Amsler Grid DIAGNOSTIC_TEST

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.

Amsler Grid

CRYSTALSIGHT DEVICE

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.

CRYSTALSIGHT Arm

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects in the age group ≥ 55 to 99 years old.
• Both genders
• Able to understand verbal spoken instructions in British/American English, Chinese or Bahasa Melayu and demonstrate device functionality and implementation.
• Able to turn on and connect the CRYSTALSIGHT device to a computer independently or with the help of family.
• Subjects undergoing treatment for Wet-AMD without any signs and symptoms of recurrence of active AMD (AMD recurrence: choroidal neovascularisation, intraretinal or subretinal fluid is present) with OCT lesion fluid volume more than 2 mm2 or ILM height more than 300µm.
• Ability to comply with the study protocol, in the investigator's judgment.
• Subjects must be able to understand and provide informed consent. A signed informed consent form must be provided before any study assessments.

You may not qualify if:

• Unable to understand verbal spoken instructions and demonstrate device functionality and implementation.
• Unable to turn on and connect the CRYSTALSIGHT device to a computer independently.
• Any ocular surgery in the previous 3 months, or vitrectomy in the previous 12 months
• Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
• 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
• Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye.
• History of idiopathic or autoimmune-associated uveitis in either eye
• Active ocular inflammation or suspected or active ocular or periocular infection in either eye.

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy; Choroidal Neovascularization

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Augustinus Laude, MBChB, MSc, FRCSEd (Ophth), FA

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

• Zheng Kuang Noel Soh, BSc

  Tan Tock Seng Hospital

  STUDY DIRECTOR

Central Study Contacts

Zheng Kuang, Noel Soh, BSc

CONTACT

+65 6357 3693; zheng.Kuang.soh@nhghealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: December 1, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)