Brief Summary

The study aims to evaluate the Automated Vision Assessment and Impairment Detection through Gaze Analysis (AVIGA) system in the ability to detect and assess central vision dysfunction in a personalized, adaptive, objective, and automated way through eye gaze tracking in age-related macular degeneration (AMD). We also aim to develop a novel algorithm / scoring methodology for disease activity monitoring over time (delta-change). AVIGA visual risk prediction cut-off scores will be presented together with probabilities of occurrence of prespecified adverse clinical outcome.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

128

participants targeted

Target at P50-P75 for all trials

Timeline

7mo left

Started Apr 2023

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.6 years study duration

Study Progress84%

Apr 2023Dec 2026

Study Start

First participant enrolled

April 18, 2023

Completed

1.3 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2024

Completed

6 days until next milestone

First Posted

Study publicly available on registry

July 24, 2024

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

3.6 years

First QC Date

July 18, 2024

Last Update Submit

January 5, 2026

Conditions

Keywords

AMDwet AMDwAMDPCVmacular degenerationgaze analysis

Outcome Measures

Primary Outcomes (1)

Correlation between AVIGA and standard clincial measures for detecting AMD activity
Assessment of the agreement between AVIGA-derived eye gaze tracking metrics and standard clinical measures of central visual function (optical coherence tomography \[OCT\], visual acuity, and fundoscopy) in detecting active aged-related macular degeneration (AMD). This outcome will determine whether AVIGA can serve as a reliable tool to detect AMD disease repeatability.
1 year

Secondary Outcomes (1)

Development and validation of an AVIGA Algorithm for tracking AMD progression
1 year

Study Arms (1)

AVIGA2

Eye gaze tracking using the AVIGA tool

Device: Automated Vision Assessment and Impairment Detection through Gaze Analysis (AVIGA) system

Interventions

Automated Vision Assessment and Impairment Detection through Gaze Analysis (AVIGA) systemDEVICE

AVIGA is an automated method and system for vision assessment of a subject. The method includes the following: determining a set of test patterns for the subject based on a preliminary assessment of an eye of the subject; displaying the set of test patterns sequentially to the subject; collecting data on the subject's gaze in response to each test pattern displayed; and correlating central vision function of the subjects to the collected gaze data. Subjects perform the AVIGA test monocularly and pursue a pre-determined target moving in a customized waveform across the computer screen. The trail of the gaze points generated by the subject following the target is simultaneously recorded and stored. 1. Static Fixation Evaluation (SFE) 2. Static Perimetry Assessment (SPA) 3. Static Perimetry Sensitivity Assessment (SPSA) 4. Pursuit

AVIGA2

Eligibility Criteria

Age55 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients of both genders aged 55 years and above diagnosed with wet AMD. Participants recruited must be cognitively coherent.

You may qualify if:

Subjects in the age group = 55 years and above.
Both genders
Subjects with Wet-AMD
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 are done.

You may not qualify if:

Uncontrolled blood pressure, defined as systolic blood pressure \>180 millimeters of mercury (mmHg) and/or diastolic blood pressure \>100 mmHg while a patient is at rest.
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
History of idiopathic or autoimmune-associated uveitis in either eye
Active ocular inflammation or suspected or active ocular or periocular infection in either eye

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Tan Tock Seng Hospitallead
Occutrack Medical Solutions Pte Ltdcollaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Related Publications (10)

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.
PMID: 28268575RESULT
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.
PMID: 29060564RESULT
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.
PMID: 10588299RESULT
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.
PMID: 24385141RESULT
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.
PMID: 22840421RESULT
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.
PMID: 24211172RESULT
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.
PMID: 22173073RESULT
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.
PMID: 29060394RESULT
Trevino R, Kynn MG. Macular function surveillance revisited. Optometry. 2008 Jul;79(7):397-403. doi: 10.1016/j.optm.2007.09.017.
PMID: 18577497RESULT
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.
PMID: 18439679RESULT

MeSH Terms

Conditions

Macular Degeneration

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

Augustinus Laude, MBChB
Tan Tock Seng Hospital
PRINCIPAL INVESTIGATOR
Zheng Kuang Noel Soh, BSc
Tan Tock Seng Hospital
STUDY DIRECTOR

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Adj A/Prof Laude Augustinus

Study Record Dates

First Submitted

July 18, 2024

First Posted

July 24, 2024

Study Start

April 18, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing: Will not share

Locations

SG(1)

Automated Vision Assessment and Impairment Detection Through Gaze Analysis in Wet AMD Patients

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

AVIGA2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

AVIGA2

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (10)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Data Sharing

Locations