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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.
Age-Related Macular Degeneration (AMD) 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.
The study team has developed a portable, self-administered online based assessment, designed for gaze-tracking and monitoring of patients with retinal diseases such as AMD, and choroidal neovascularization (CNV) that require multiple anti-VEGF injections.
The team have confirmed the performance of the AVIGA system 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 an open-labelled, randomized clinical trial (RCT) to compare the efficacy and cost-effectiveness of a Pro Re Nana (PRN) management regimen enhanced with the AVIGA home-monitoring platform for the detection of central metamorphopsia with existing PRN standard of care for patients with AMD exiting the anti-VEGF injection regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| AVIGA Arm | Experimental | The AVIGA system tracks eye movements following generated patterns projected on the screen. Assessment of affected and unaffected eyes can be achieved at home using any computer screen. AVIGA is a home-based gaze-tracking system for monitoring of high-risk eyes with wet-AMD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic Accuracy Using One-Sided Confidence Interval or One-Sided Hypothesis Test | 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. | 12 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation with Optical Coherence Tomography (OCT) | To determine the correlation between AVIGA gaze scores and average OCT height readings | 12 Months |
| User Experience & Functionality | Qualitative assessment of usability and patient adherence to the home testing protocol will be conducted by evaluating completion rates of AVIGA testing twice weekly. Consistent compliance will be interpreted as an indicator of protocol feasibility and user-friendliness, suggesting that the testing procedure was sufficiently accessible and manageable for patients to maintain regular adherence. |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zheng Kuang, Noel Soh, BSc | Contact | +65 6357 3693 | zheng.Kuang.soh@nhghealth.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Augustinus Laude, MBChB, MSc, FRCSEd (Ophth), FA | Tan Tock Seng Hospital | Principal Investigator |
| Zheng Kuang Noel Soh, BSc | Tan Tock Seng Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tan Tock Seng Hospital | Recruiting | Singapore | 308433 | Singapore |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 22, 2025 | Jun 17, 2026 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
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| AVIGA | Device | 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. |
|
| 12 Months |
| D014603 |
| Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |