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NCT Number: NCT07338513

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

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.

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Key information

Age range

55 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tan Tock Seng Hospital

Singapore, 308433

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects in the age group ≥ 55 to 99 years old.
  • Both genders
  • Able to understand verbal spoken instructions in British/American English, Chinese or Bahasa Melayu and demonstrate device functionality and implementation.
  • 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.
  • 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.

Exclusion criteria

  • Unable to understand verbal spoken instructions and demonstrate device functionality and implementation.
  • Unable to turn on and connect their computer to the AVIGA platform independently.
  • Any ocular surgery in the previous 3 months, or vitrectomy in the previous 12 months
  • 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
  • Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye.
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Active ocular inflammation or suspected or active ocular or periocular infection in either eye.
  • Severe cognitive impairment, comorbid conditions severely limiting participation (e.g., advanced hearing loss)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zheng Kuang Noel Soh, BSc

CONTACT

[email protected]

+65 6256 6011

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Acronym: AVIGA-SURVEY

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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