AVIGA3 (Cohort 2.0) (AVIGA3)

June 21, 2026 updated by: Laude Augustinus, Tan Tock Seng Hospital

AVIGA3: Using an 'Automated Vision Assessment and Impairment Detection Through Gaze Analysis' Through a Longitudinal, Open-labelled, Randomized Clinical Trial to Monitor Recurrence of Aged-related Macular Degeneration in a Home-based Setting (Cohort 2.0).

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
        • Recruiting
        • Tan Tock Seng Hospital
        • Sub-Investigator:
          • Tock Han Lim, MBBS, FRCSEd, MMed (Ophth)
        • Contact:
        • Sub-Investigator:
          • Zheng Kuang Noel Soh, BSc
        • Principal Investigator:
          • Augustinus Laude, MBChB
        • Sub-Investigator:
          • Elizabeth May Tan Chin, Doctor of Medicine
        • Sub-Investigator:
          • Ian Kai Wen Yeo, BSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
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.
Experimental: AVIGA Arm

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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Accuracy Using One-Sided Confidence Interval or One-Sided Hypothesis Test
Time Frame: 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.
12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation with Optical Coherence Tomography (OCT)
Time Frame: 12 Months
To determine the correlation between AVIGA gaze scores and average OCT height readings
12 Months
User Experience & Functionality
Time Frame: 12 Months
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.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Investigators

  • Principal Investigator: Augustinus Laude, MBChB, MSc, FRCSEd (Ophth), FA, Tan Tock Seng Hospital
  • Study Director: Zheng Kuang Noel Soh, BSc, Tan Tock Seng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

June 23, 2025

First Submitted That Met QC Criteria

November 20, 2025

First Posted (Actual)

December 1, 2025

Study Record Updates

Last Update Posted (Actual)

June 24, 2026

Last Update Submitted That Met QC Criteria

June 21, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-3705

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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