Health TrialsbyHealthPanel

AVIGA3 (Cohort 2.0)

ConditionMaculopathy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-99
SponsorTan Tock Seng Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Amsler Grid

    Diagnostic test

    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.

  • AVIGA

    Device

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Amsler GridActive comparator 1 intervention
Group B: AVIGA ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Diagnostic Accuracy Using One-Sided Confidence Interval or One-Sided Hypothesis Test

To assess whether the AVIGA device is non-inferior to the standard of care (Amsler grid) in detecting recurrence of wet-AMD during patient recall, by comparing both generated scores, validated by OCT readings.

Time frame
12 Months

Secondary outcomes

1

Correlation with Optical Coherence Tomography (OCT)

To determine the correlation between AVIGA gaze scores and average OCT height readings

Time frame
12 Months
2

User Experience & Functionality

Qualitative assessment of usability and patient adherence to the home testing protocol will be conducted by evaluating completion rates of AVIGA testing twice weekly. Consistent compliance will be interpreted as an indicator of protocol feasibility and user-friendliness, suggesting that the testing procedure was sufficiently accessible and manageable for patients to maintain regular adherence.

Time frame
12 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tan Tock Seng Hospital

Lead sponsor

Source ClinicalTrials.gov
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