Late-Onset Retinal Degeneration Clinical Trials

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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).

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Singapore
Tan Tock Seng Hospital
RECRUITING
Singapore
Contact Information
Primary
Zheng Kuang, Noel Soh, BSc
zheng.Kuang.soh@nhghealth.com.sg
+65 6357 3693
Time Frame
Start Date: 2025-06-16
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 60
Treatments
Active_comparator: 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.
Experimental: AVIGA Arm
The AVIGA system tracks eye movements following generated patterns projected on the screen. Assessment of affected and unaffected eyes can be achieved at home using any computer screen.~AVIGA is a home-based gaze-tracking system for monitoring of high-risk eyes with wet-AMD.
Sponsors
Leads: Tan Tock Seng Hospital

This content was sourced from clinicaltrials.gov