Clinical trial NCT06518512: Automated Vision Assessment and Impairment Detection Through Gaze Analysis in Wet AMD Patients
Official title: Automated Vision Assessment and Impairment Detection Through Gaze Analysis in Wet Age Related Macular Degeneration (AMD) Patients: a Prospective Clinical Evaluation (AVIGA2)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Age-Related Macular Degeneration
Wet Age-related Macular Degeneration
Keywords: AMD
wet AMD
wAMD
PCV
macular degeneration
gaze analysis
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: Occutrack Medical Solutions Pte Ltd
First posted: 2024-07-24
Enrollment: 128
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of both genders aged 55 years and above diagnosed with wet AMD. Participants recruited must be cognitively coherent.

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.

Detailed description: Macula degeneration is more prevalent with ageing and can result in blurred or distorted vision, often accompanied by a dark patch blocking the center of the visual field. In the management of age-related macular degeneration (AMD), patients are required to attend regular check-ups at the specialist eye clinic by the clinician to monitor if their disease. The eye examinations that patients undergo during these clinic visits which may include fundoscopy and optical coherence tomography. A preventive treatment for exudative or wet AMD is the administration of an intravitreal injection of an anti-vascular endothelial growth factor (anti- VEGF) at these regular clinic sessions. Although anti-vascular endothelial growth factor (VEGF) injections are an effective treatment for many patients with Wet-AMD, there are several unmet needs in treatment of AMD and none of them cures the disease or reverses its course. Some patients do not respond to VEGF injections. There are no standardized treatment schedules, there is a large treatment burden, and visual loss continues over time. Additionally, the main drawback of anti-VEGF therapy is its high cost, which suppose a significant burden on health systems, and often makes such a regimen unaffordable in clinical practice.

There is no treatment for GA. Therefore, the prevention of advanced disease like Wet-AMD and finding new and effective treatments remain a significant challenge. Advances in imaging and genetics and molecular technologies have led to the identification of new risk factors for disease progression, but not all have been evaluated in comprehensive prediction models. Perhaps, comprehensive prediction models could lead to the development of tailored, individualized therapy and improve the personalised healthcare.As such, the application of this Novel OCCUTRACK Technology to develop a comprehensive risk score algorithm and to estimate the risk scores to identify individuals at high risk for disease progression to advanced stages would result in earlier intervention and reduced burden of visual loss due to AMD. This approach could enable the tailored individualized Anti-VEGF Therapy to promote personalized medicine and improve the quality of life of patients with Wet-AMD. A Proof-of-Concept (POC) was completed by TTSH clinician and AStar-I2R scientist to co-develop and patent a software - Automated Vision Assessment and Impairment Detection through Gaze Analysis (AVIGA). A local medical incubator, Trendlines Medical Singapore, has licensed it from the research party. This led to the spin-off of a new company - Occutrack Pte Ltd to continue the collaboration with TTSH, focusing on the commercialization of the AVIGA. The AVIGA system incorporates an ocular tracking system with gaze tracking algorithms designed to provide a comprehensive assessment of a patient's vision. With this non-invasive technology, retinal specialists can monitor the real time progression and prognosis of patients with AMD while they are in the comfort of their own home without the need for manual or skilled intervention and expensive equipment. This project proposal is to evaluate the performance and accuracy of the AVIGA technology as a tool for determining AMD disease activity.

Eligibility criteria: Inclusion Criteria:

* 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\&#39;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.

Exclusion Criteria:

* Uncontrolled blood pressure, defined as systolic blood pressure \&gt;180 millimeters of mercury (mmHg) and/or diastolic blood pressure \&gt;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
* Other protocol-specified exclusion criteria may apply

Primary outcomes:
measure: Correlation between AVIGA and standard clincial measures for detecting AMD activity
timeFrame: 1 year
Secondary outcomes:
measure: Development and validation of an AVIGA Algorithm for tracking AMD progression
timeFrame: 1 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Augustinus Laude, MBChB
role: PRINCIPAL_INVESTIGATOR
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