Clinical trial NCT06465212: Personalized Shared Eye-care Identification of Age-related Macular Degeneration Using Artificial Intelligence and Telemedicine by Matching Optometrist Office-based Sites With Clinical Supervision
Official title: Personalized Shared Eye-care Identification of Age-related Macular Degeneration Using Artificial Intelligence and Telemedicine in a Prospective, Exploratory, Multinational, Multicentre Cross-sectional Study Matching Optometrist Office-based Sites With Clinical Supervision
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Age-Related Macular Degeneration
Keywords: Telemedicine
Ophthalmic Coherence Tomography
Shared-care
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2024-06-18
Enrollment: 5000
Sex: ALL
Minimum age (years): 55
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Allcomers at the optometrist office that meet the inclusion criteria. In general, there is no specific targeting in recruitment. This collection of data does not represent a traditional clinical study that is recruiting patients, but is exclusively collecting images from asymptomatic individuals.

Individuals are imaged within the practice routine of optometrists/opticians. If, in this consecutive series, an individual meets the inclusion criteria for the study, the image is uploaded to the platform. A board-certified ophthalmologist at the Medical University of Vienna then systematically checks all images individually and informs the optometrist about the need for local ophthalmologist referral.

Brief summary: Office-based optometrist centres equipped with low-cost OCT devices can be used for screening of age-related macular degeneration. Matching next-door optometrist centres with clinical sites introduces a shared care service in an unprecedented and broad manner and offers timely and inclusive access to eye care for all citizens affected by the most frequent blinding disease in western countries.

The aim of the study is to detect AMD in a next-door office-based setting on an individual level using low-cost OCT, through a telemedicine feedback loop.

The specific aims of this study are:

* Setting up a network of optometrist centres matched to clinical sites to perform shared care to protect eyesight in the elderly population.
* Identify imaging biomarkers of age-related macular degeneration from OCT imaging.
* Give a risk estimation of progression using a one-time low-cost OCT scan


Eligibility criteria: Inclusion Criteria:

* Age: 55-99 years old
* Preserved visual function, defined as visual acuity better than or equal to 0.3logMAR in one or both eyes

Exclusion Criteria:

* Refractive errors with mean spherical equivalent (MSE) greater than +/-6.00, with no limit to astigmatic component.

Primary outcomes:
measure: Identification of different AMD stages on OCT images from a community-based setting to calculate the real-world prevalence of AMD
timeFrame: 2 years
Secondary outcomes:
measure: Further biomarkers of AMD that are expected to be present in the cohort will be analyzed in order to assess whether they can be identified and quantified in this real-world cohort.
timeFrame: 2 years
measure: As a post-hoc analysis, the diagnostic accuracy of AI algorithms to recognize changes associated with age-related macular degeneration in OCT volumes, will be evaluated in this real-world cohort.
timeFrame: 2 years
Other outcomes:
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Study officials:
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