AVIGA3 (Cohort 2.0)

Official title

AVIGA3: Using an 'Automated Vision Assessment and Impairment Detection Through Gaze Analysis' Through a Longitudinal, Open-labelled, Randomized Clinical Trial to Monitor Recurrence of Aged-related Macular Degeneration in a Home-based Setting (Cohort 2.0).

Overview

Age-Macular Degeneration (AMD) is a common eye condition and a leading cause of vision loss among people age 50 and older. It causes damage to the macula, a small area near the centre of the retina needed for sharp, central vision. It is estimated that the prevalence of early and late AMD in Asian populations aged 40 to 79 were 6.8% and 0.56% respectively. Prevalence in white populations estimated from large population studies were 8.8% and 0.59% respectively. With the aging population and people living longer, these numbers will only increase. Hence, this study aims to develop a system to evaluate the AVIGA system through remote monitoring for disease recurrence of wet aged-related macular degeneration using eye gaze tracking.

Detailed description

Age-Related Macular Degeneration (AMD) is one of the main causes of central vision loss. Most patients require pharmacologic treatment with anti-vascular endothelial growth factor (VEGF) agents with multiple follow-up visits that include optical coherence tomography (OCT), visual acuity testing and multiple injections.

The high frequency of visits puts pressure on eye clinics and can be extremely stressful for both patients and their caregivers. Therefore, portable and rapidly deployable self-administered home-based examination devices are key to making telemedicine a reality.

The study team has developed a portable, self-administered online based assessment, designed for gaze-tracking and monitoring of patients with retinal diseases such as AMD, and choroidal neovascularization (CNV) that require multiple anti-VEGF injections.

The team have confirmed the performance of the AVIGA system and validated the retinal thickness measurements obtained with this device by comparing it to in-hospital Optical Coherence Tomography (OCT) (Heidelberg Spectralis). In this study, the team will conduct an open-labelled, randomized clinical trial (RCT) to compare the efficacy and cost-effectiveness of a Pro Re Nana (PRN) management regimen enhanced with the AVIGA home-monitoring platform for the detection of central metamorphopsia with existing PRN standard of care for patients with AMD exiting the anti-VEGF injection regimen.

Interventions

• Diagnostic test Amsler Grid
  The Amsler grid is a tool used to monitor the macula, the central part of the retina, for changes in vision that can be indicative of various eye conditions, particularly age-related macular degeneration (AMD). It helps detect and monitor metamorphopsia (distorted vision) or scotoma (blind spots) in the central visual field.
• Device AVIGA
  The AVIGA system tracks these eye movements with generated patterns on the screen, a visual assessment of affected and unaffected eyes is achieved at home on any tablet or laptop computer. AVIGA is a home-based gaze-tracking system for hyperacuity monitoring of high-risk eyes with diagnosed wet-AMD.

Primary outcome measures

• Diagnostic Accuracy Using One-Sided Confidence Interval or One-Sided Hypothesis Test [Time frame: 12 Months]

Secondary outcome measures (2)

• Correlation with Optical Coherence Tomography (OCT) [Time frame: 12 Months]
• User Experience & Functionality [Time frame: 12 Months]

Eligibility criteria

Inclusion criteria

• Subjects in the age group ≥ 50 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.
• Able to turn on and connect the web-camera to a computer independently or with the help of family.
• 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 2 mm3 or ILM height more than 250µm.
• 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 the web-camera to a computer 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Diagnostic

Study locations

Singapore · 1 center

• Tan Tock Seng Hospital — Singapore

Identifiers

NCT: NCT07255859 · 2024-3705

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗