RECRUITINGINTERVENTIONAL

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).

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subjects in the age group ≥ 55 to 99 years old. 2. Both genders 3. Able to understand verbal spoken instructions in British/American English, Chinese or Bahasa Melayu and demonstrate device functionality and implementation. 4. Able to turn on and connect the CRYSTALSIGHT device to a computer independently or with the help of family. 5. 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. 6. Ability to comply with the study protocol, in the investigator's judgment. 7. Subjects must be able to understand and provide willing to sign a consent form. A signed willing to sign a consent form form must be provided before any study assessments. Who Should NOT Join This Trial: 1. Unable to understand verbal spoken instructions and demonstrate device functionality and implementation. 2. Unable to turn on and connect the CRYSTALSIGHT device to a computer independently. 3. Any ocular surgery in the previous 3 months, or vitrectomy in the previous 12 months 4. Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye 5. 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 6. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye. 7. History of idiopathic or autoimmune-associated uveitis in either eye 8. Active ocular inflammation or suspected or active ocular or periocular infection in either eye. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Subjects in the age group ≥ 55 to 99 years old. 2. Both genders 3. Able to understand verbal spoken instructions in British/American English, Chinese or Bahasa Melayu and demonstrate device functionality and implementation. 4. Able to turn on and connect the CRYSTALSIGHT device to a computer independently or with the help of family. 5. 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. 6. Ability to comply with the study protocol, in the investigator's judgment. 7. Subjects must be able to understand and provide informed consent. A signed informed consent form must be provided before any study assessments. Exclusion Criteria: 1. Unable to understand verbal spoken instructions and demonstrate device functionality and implementation. 2. Unable to turn on and connect the CRYSTALSIGHT device to a computer independently. 3. Any ocular surgery in the previous 3 months, or vitrectomy in the previous 12 months 4. Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye 5. 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 6. Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye. 7. History of idiopathic or autoimmune-associated uveitis in either eye 8. Active ocular inflammation or suspected or active ocular or periocular infection in either eye.

Treatments Being Tested

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.

Locations (1)

Tan Tock Seng Hospital

Singapore, Singapore