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

NCT ID: NCT07338513

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-09-30

Brief Summary

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.

Conditions

Age-Related Macular Degeneration; Wet Age-related Macular Degeneration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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)

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tan Tock Seng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Laude Augustinus

Senior Consultant

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Augustinus Laude, MBChB

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Zheng Kuang Noel Soh, BSc

Role: STUDY_DIRECTOR

Tan Tock Seng Hospital

Locations

Tan Tock Seng Hospital

Singapore, , Singapore

Countries

Singapore

Central Contacts

Zheng Kuang Noel Soh, BSc

Role: CONTACT

zheng.kuang.soh@nhghealth.com.sg

+65 6256 6011

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Brooke, John.

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Davis, Fred D.

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Other Identifiers

2025-1535

Identifier Type: -

Identifier Source: org_study_id