User-centric Study of Patients' Receptiveness Towards the Web-based Automated Vision Impairment Gaze-tracking Analysis Systems (AVIGA-SURVEY)

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

Age-Related Macular Degeneration (AMD) is the leading cause of central vision loss among older adults worldwide. Patients with AMD often require frequent monitoring of visual function and disease progression, typically through multiple follow-up visits involving optical coherence tomography (OCT), visual acuity testing (VA), and clinical consultations.

While digital self-monitoring tools have emerged as promising solutions to reduce the burden of in-clinic visits, many elderly patients face challenges in engaging with these platforms due to visual impairment, limited digital literacy, and poorly optimised user interfaces. These barriers may reduce patient willingness to adopt such systems and undermine their long-term effectiveness.

To address this gap, the study team has developed the web-based AVIGA (Automated Vision Impairment Gaze-tracking Analysis) system, which is a portable, self-administered, home-based digital monitoring system designed to minimise cognitive load and maximise usability for elderly AMD patients. The platform integrates patient-centred design principles such as simplified navigation, optimised text, and multimodal feedback (visual and audio) to empower users to independently track their visual health.

A prospective, single-site usability trial to evaluate the AVIGA platform using validated human factors measures: the System Usability Scale (SUS), the Technology Acceptance Model (TAM) will be conducted. By examining the relationship between usability, cognitive load, and perceived empowerment, this study aims to identify critical user interface and user experience (UI/UX) design factors that influence willingness to adopt and sustain use of digital health tools among elderly AMD patients.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

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
        • 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 previously recruited with recurrent vision problems diagnosed with active Wet-AMD at the TTSH Specialist Outpatient Clinic.

Description

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. 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 2mm2 or ILM height more than 300µm.
  5. Ability to comply with the study protocol, in the investigator's judgment.
  6. 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 their computer to the AVIGA platform 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.
  9. Severe cognitive impairment, comorbid conditions severely limiting participation (e.g., advanced hearing loss)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess System Usability
Time Frame: Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months)
Measure and evaluate overall system usability across three checkpoints (Baseline, Mid-point, and End-point) using the System Usability Scale (SUS), a 10-item questionnaire rated on a 5-point Likert scale.
Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months)
Assess System Acceptance
Time Frame: Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months)
Measure and evaluate overall acceptance towards system adoption across three checkpoints (Baseline, Mid-point, and End-point) using 8 items from the Technology Acceptance Model (TAM), rated on a 5-point Likert scale.
Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Track Change Over Time
Time Frame: Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months)
Compare the changes in expectation (Baseline) versus lived experience (Mid-point, End-point) scores taken from the combined SUS and TAM to identify how usability perceptions and adoption intentions evolve with continued use.
Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 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, 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

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 (Estimated)

January 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 14, 2026

Study Record Updates

Last Update Posted (Actual)

January 14, 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

  • 2025-1535

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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