ClinicalTrials.gg
Enrolling by invitationNCT07338513AVIGA-SURVEYUpdated Oct 2, 2026

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

An observational study in Age-Related Macular Degeneration and Wet Age-related Macular Degeneration, sponsored by Tan Tock Seng Hospital. Enrolling by invitation at 1 site in Singapore. Open to participants aged 55 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-10-02.

Sponsored by Tan Tock Seng Hospital · Observational

Updated Oct 2, 2026Now Enrolling by invitationStart date movedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
30
Ages
55 Years to 99 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Age-Related Macular Degeneration
  • Wet Age-related Macular Degeneration

Keywords

  • user interface
  • user experience
  • Technology Acceptance Model
  • System Usability Scale
03

In context

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 238 are open to participants now.

This study's planned enrollment of 30 is below the median of 110 across 409 observational studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Tan Tock Seng Hospital is the lead sponsor of 108 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 99 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 . A signed informed consent form must be provided before any study assessments.

Exclusion criteria

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 -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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

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

Secondary outcomes

  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.

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

07

Study locations

1 site
08

References and documents

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.
  • Davis, Fred D.
09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2026 (actual). Primary completion is estimated for Jul 2027, 15 months after the start.

Of 104 non-industry observational studies under Macular Degeneration, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 98. This study's planned 15 months is below that.

Counting every sponsor, half of 160 studies reached it within 45 months; a quarter within 16 and three quarters within 77.

Start moved once since we started tracking on Sep 25, 2026: Jan 2026 → Apr 2026, on Oct 2, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2025
First posted
Jan 14, 2026
StartActual
Apr 1, 2026was Jan 2026
Primary completionEst.
Jul 2027
CompletionEst.
Sep 2027
Last update
Oct 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Enrolling by invitation
changed Oct 2, 2026
Start date
Jan 2026→Apr 1, 2026 (actual)
Oct 2, 2026
Contact
No study contact listed any more: removed z•••@nhghealth.com.sg · •••6011
Oct 2, 2026
Show all 1 update
  1. Oct 2, 2026
    Not yet recruiting→Enrolling by invitation
    Start date Jan 2026→Apr 1, 2026 (now actual)
    Contact No study contact listed any more: removed z•••@nhghealth.com.sg · •••6011
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07338513
Responsible party
Laude Augustinus (Senior Consultant, Tan Tock Seng Hospital) — Principal investigator
First posted
Jan 14, 2026
Start date
Apr 1, 2026
Primary completion
Jul 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Oct 2, 2026

Study contacts

Augustinus Laude, MBChB
principal investigator · Tan Tock Seng Hospital
Zheng Kuang Noel Soh, BSc
study director · Tan Tock Seng Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion