Automated Vision Assessment and Impairment Detection Through Gaze Analysis in Wet AMD Patients (AVIGA2)

January 5, 2026 updated by: Laude Augustinus, Tan Tock Seng Hospital

Automated Vision Assessment and Impairment Detection Through Gaze Analysis in Wet Age Related Macular Degeneration (AMD) Patients: a Prospective Clinical Evaluation (AVIGA2)

The study aims to evaluate the Automated Vision Assessment and Impairment Detection through Gaze Analysis (AVIGA) system in the ability to detect and assess central vision dysfunction in a personalized, adaptive, objective, and automated way through eye gaze tracking in age-related macular degeneration (AMD). We also aim to develop a novel algorithm / scoring methodology for disease activity monitoring over time (delta-change). AVIGA visual risk prediction cut-off scores will be presented together with probabilities of occurrence of prespecified adverse clinical outcome.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Macula degeneration is more prevalent with ageing and can result in blurred or distorted vision, often accompanied by a dark patch blocking the center of the visual field. In the management of age-related macular degeneration (AMD), patients are required to attend regular check-ups at the specialist eye clinic by the clinician to monitor if their disease. The eye examinations that patients undergo during these clinic visits which may include fundoscopy and optical coherence tomography. A preventive treatment for exudative or wet AMD is the administration of an intravitreal injection of an anti-vascular endothelial growth factor (anti- VEGF) at these regular clinic sessions. Although anti-vascular endothelial growth factor (VEGF) injections are an effective treatment for many patients with Wet-AMD, there are several unmet needs in treatment of AMD and none of them cures the disease or reverses its course. Some patients do not respond to VEGF injections. There are no standardized treatment schedules, there is a large treatment burden, and visual loss continues over time. Additionally, the main drawback of anti-VEGF therapy is its high cost, which suppose a significant burden on health systems, and often makes such a regimen unaffordable in clinical practice.

There is no treatment for GA. Therefore, the prevention of advanced disease like Wet-AMD and finding new and effective treatments remain a significant challenge. Advances in imaging and genetics and molecular technologies have led to the identification of new risk factors for disease progression, but not all have been evaluated in comprehensive prediction models. Perhaps, comprehensive prediction models could lead to the development of tailored, individualized therapy and improve the personalised healthcare.As such, the application of this Novel OCCUTRACK Technology to develop a comprehensive risk score algorithm and to estimate the risk scores to identify individuals at high risk for disease progression to advanced stages would result in earlier intervention and reduced burden of visual loss due to AMD. This approach could enable the tailored individualized Anti-VEGF Therapy to promote personalized medicine and improve the quality of life of patients with Wet-AMD. A Proof-of-Concept (POC) was completed by TTSH clinician and AStar-I2R scientist to co-develop and patent a software - Automated Vision Assessment and Impairment Detection through Gaze Analysis (AVIGA). A local medical incubator, Trendlines Medical Singapore, has licensed it from the research party. This led to the spin-off of a new company - Occutrack Pte Ltd to continue the collaboration with TTSH, focusing on the commercialization of the AVIGA. The AVIGA system incorporates an ocular tracking system with gaze tracking algorithms designed to provide a comprehensive assessment of a patient's vision. With this non-invasive technology, retinal specialists can monitor the real time progression and prognosis of patients with AMD while they are in the comfort of their own home without the need for manual or skilled intervention and expensive equipment. This project proposal is to evaluate the performance and accuracy of the AVIGA technology as a tool for determining AMD disease activity.

Study Type

Observational

Enrollment (Estimated)

128

Contacts and Locations

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

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital

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

Sampling Method

Non-Probability Sample

Study Population

Patients of both genders aged 55 years and above diagnosed with wet AMD. Participants recruited must be cognitively coherent.

Description

Inclusion Criteria:

  • Subjects in the age group = 55 years and above.
  • Both genders
  • Subjects with Wet-AMD
  • 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 are done.

Exclusion Criteria:

  • Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest.
  • 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
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Active ocular inflammation or suspected or active ocular or periocular infection in either eye
  • Other protocol-specified exclusion criteria may apply

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AVIGA2
Eye gaze tracking using the AVIGA tool
Device: Automated Vision Assessment and Impairment Detection through Gaze Analysis (AVIGA) system

AVIGA is an automated method and system for vision assessment of a subject. The method includes the following: determining a set of test patterns for the subject based on a preliminary assessment of an eye of the subject; displaying the set of test patterns sequentially to the subject; collecting data on the subject's gaze in response to each test pattern displayed; and correlating central vision function of the subjects to the collected gaze data.

Subjects perform the AVIGA test monocularly and pursue a pre-determined target moving in a customized waveform across the computer screen. The trail of the gaze points generated by the subject following the target is simultaneously recorded and stored.

  1. Static Fixation Evaluation (SFE)
  2. Static Perimetry Assessment (SPA)
  3. Static Perimetry Sensitivity Assessment (SPSA)
  4. Pursuit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between AVIGA and standard clincial measures for detecting AMD activity
Time Frame: 1 year
Assessment of the agreement between AVIGA-derived eye gaze tracking metrics and standard clinical measures of central visual function (optical coherence tomography [OCT], visual acuity, and fundoscopy) in detecting active aged-related macular degeneration (AMD). This outcome will determine whether AVIGA can serve as a reliable tool to detect AMD disease repeatability.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development and validation of an AVIGA Algorithm for tracking AMD progression
Time Frame: 1 year
Evaluation of a new AVIGA algorithm to detect longitudinal changes in visual function and disease activity in AMD patients. The algorithm's outputs will be compared against changes observed in OCT, visual acuity, and fundus imaging over time. This outcome will assess the algorithm's ability to track disease progression and treatment response quantitatively.
1 year

Collaborators and Investigators

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

Sponsor

Tan Tock Seng Hospital

Collaborators

Occutrack Medical Solutions Pte Ltd

Investigators

  • Principal Investigator: Augustinus Laude, MBChB, Tan Tock Seng Hospital
  • Study Director: Zheng Kuang Noel Soh, BSc, Tan Tock Seng Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

April 18, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

July 18, 2024

First Submitted That Met QC Criteria

July 18, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 5, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/00600

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

product manufactured in and exported from the U.S.

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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