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AzTrials

Age-Related Macular DegenerationAVIGA-SURVEYNCT07338513

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

An observational study of Age-Related Macular Degeneration and Wet Age-related Macular Degeneration, run by Tan Tock Seng Hospital at 1 site in Singapore.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 55 to 99 years
How many people
30 participants
Where
1 siteSingapore
Study dates
1 Apr 2026to Sep 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients previously recruited with recurrent vision problems diagnosed with active Wet-AMD at the TTSH Specialist Outpatient Clinic.

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Singapore1 site

  • Tan Tock Seng Hospital

    Singapore, 308433

Other trials in Singapore

About this study

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.

Read more

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.

Keywords
user interface, user experience, Technology Acceptance Model, System Usability Scale
Medical subject headings
Macular Degeneration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess System Usability

    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.

    Measured: Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months)

  2. Assess System Acceptance

    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.

    Measured: Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months)

Secondary outcomes (1)

  1. Track Change Over Time

    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.

    Measured: Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2026
  2. Study start1 Apr 2026
  3. Primary completionJul 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07338513
Sponsor's protocol ID
2025-1535
Acronym
AVIGA-SURVEY
Status last verified
Sep 2026
First submitted
20 Nov 2025
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Huiying Liu, Wong D, Ai Ping Yow, Yanwu Xu, Fengshou Yin, Laude A, Tock Han Lim. Determining the difference in eyegaze measurements in individuals with age related macular degeneration. Annu Int Conf IEEE Eng Med Biol Soc. 2016 Aug;2016:1348-1351. doi: 10.1109/EMBC.2016.7590957.

    PubMed 28268575

  • Huiying Liu, Yanwu Xu, Damon Wong, Ai Ping Yow, Laude A, Tock Han Lim. Detecting impaired vision caused by AMD from gaze data. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:3142-3145. doi: 10.1109/EMBC.2017.8037523.

    PubMed 29060564

  • Liu, H., et al., Vision assessment based on gaze. 2019, AGENCY FOR SCIENCE, TECHNOLOGY AND RESEARCH [SG/SG]; 1 Fusionopolis Way, #20-10 Connexis North Tower, Singapore 138632, SG: Singapore.

  • Goldberg, J.H. and X.P. Kotval, Computer interface evaluation using eye movements: methods and constructs. International journal of industrial ergonomics, 1999. 24(6): p. 631-645.

  • Loewenstein A; Richard & Hinda Rosenthal Foundation. The significance of early detection of age-related macular degeneration: Richard & Hinda Rosenthal Foundation lecture, The Macula Society 29th annual meeting. Retina. 2007 Sep;27(7):873-8. doi: 10.1097/IAE.0b013e318050d2ec.

    PubMed 17891011

  • Goldberg, J.H. and A.M. Wichansky, Eye tracking in usability evaluation: A practitioner's guide, in the Mind's Eye. 2003, Elsevier. p. 493-516.

  • Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study (AREDS): design implications. AREDS report no. 1. Control Clin Trials. 1999 Dec;20(6):573-600. doi: 10.1016/s0197-2456(99)00031-8.

    PubMed 10588299

  • Chew EY, Clemons TE, Agron E, Sperduto RD, Sangiovanni JP, Davis MD, Ferris FL 3rd; Age-Related Eye Disease Study Research Group. Ten-year follow-up of age-related macular degeneration in the age-related eye disease study: AREDS report no. 36. JAMA Ophthalmol. 2014 Mar;132(3):272-7. doi: 10.1001/jamaophthalmol.2013.6636.

    PubMed 24385141

  • AREDS2 Research Group; Chew EY, Clemons T, SanGiovanni JP, Danis R, Domalpally A, McBee W, Sperduto R, Ferris FL. The Age-Related Eye Disease Study 2 (AREDS2): study design and baseline characteristics (AREDS2 report number 1). Ophthalmology. 2012 Nov;119(11):2282-9. doi: 10.1016/j.ophtha.2012.05.027. Epub 2012 Jul 26.

    PubMed 22840421

  • AREDS2-HOME Study Research Group; Chew EY, Clemons TE, Bressler SB, Elman MJ, Danis RP, Domalpally A, Heier JS, Kim JE, Garfinkel R. Randomized trial of a home monitoring system for early detection of choroidal neovascularization home monitoring of the Eye (HOME) study. Ophthalmology. 2014 Feb;121(2):535-44. doi: 10.1016/j.ophtha.2013.10.027. Epub 2013 Nov 8.

    PubMed 24211172

  • Mathew R, Sivaprasad S. Environmental Amsler test as a monitoring tool for retreatment with ranibizumab for neovascular age-related macular degeneration. Eye (Lond). 2012 Mar;26(3):389-93. doi: 10.1038/eye.2011.326. Epub 2011 Dec 16.

    PubMed 22173073

  • Ai Ping Yow, Damon Wong, Huiying Liu, Hongyuan Zhu, Ivy Jing-Wen Ong, Laude A, Tock Han Lim. Automatic visual impairment detection system for age-related eye diseases through gaze analysis. Annu Int Conf IEEE Eng Med Biol Soc. 2017 Jul;2017:2450-2453. doi: 10.1109/EMBC.2017.8037352.

    PubMed 29060394

  • Trevino R, Kynn MG. Macular function surveillance revisited. Optometry. 2008 Jul;79(7):397-403. doi: 10.1016/j.optm.2007.09.017.

    PubMed 18577497

  • Kawasaki R, Wang JJ, Aung T, Tan DT, Mitchell P, Sandar M, Saw SM, Wong TY; Singapore Malay Eye Study Group. Prevalence of age-related macular degeneration in a Malay population: the Singapore Malay Eye Study. Ophthalmology. 2008 Oct;115(10):1735-41. doi: 10.1016/j.ophtha.2008.02.012. Epub 2008 Apr 25.

    PubMed 18439679

  • Brooke, John.

Questions about this trial

What is this clinical trial studying?

An observational study of Age-Related Macular Degeneration and Wet Age-related Macular Degeneration, run by Tan Tock Seng Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess System Usability (time frame: Baseline, Mid-point (6 months from baseline ±3 months), End-point (12 months from baseline ±3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07338513, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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