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.
AVIGA: The AVIGA system tracks these eye movements with generated patterns on the screen, a visual assessment of affected and unaffected eyes is achieved at home on any tablet or laptop computer.
AVIGA is a home-based gaze-tracking system for hyperacuity monitoring of high-risk eyes with diagnosed wet-AMD.
Study 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 the AVIGA system through remote monitoring for disease recurrence of wet aged-related macular degeneration using eye gaze tracking.
Eligibility
Sex
ALL
Min age
50 Years
Max age
99 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects in the age group ≥ 50 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 web-camera 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 mm3 or ILM height more than 250µm.
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 web-camera 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.
Primary outcome measure(s)
Diagnostic Accuracy Using One-Sided Confidence Interval or One-Sided Hypothesis Test — 12 Months To assess whether the AVIGA 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.