Personalized Shared Eye-care Identification of Age-related Macular Degeneration Using Artificial Intelligence and Telemedicine by Matching Optometrist Office-based Sites With Clinical Supervision

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

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Key information

Conditions

Age-Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

55 year–99 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TopCon Maestro 2 OCT

Device

Ophthalmic Coherence Tomography

Primary outcomes

Identification of different AMD stages on OCT images from a community-based setting to calculate the real-world prevalence of AMD

Time frame: 2 years
AMD staging will be carried out by a certified ophthalmologist at the Medical University of Vienna according to the following parameters:
- Healthy aging retina, including drupelets < 63 µm [3]
- Early AMD as defined in the protocol [3] (see 7.3 disease definitions): Medium drusen >63 µm and >125 µm. No AMD pigmentary abnormalities.
- Intermediate AMD as defined in the protocol [3] (see 7.3 disease definitions): Large druse > 125 µm and/or and pigmentary abnormalities
- Late AMD: Geographic Atrophy as defined in the protocol [3,6] (see 7.3 disease definitions)
- Other diseases: including neovascular AMD, RVO, DME, CCS, Stargardt disease, Pattern dystrophy, etc.

Secondary outcomes

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.

Time frame: 2 years
Biomarkers include:
- Drusen presence/Refractile drusen/Hyporeflective Core Drusen (yes/no)
- Hyperreflective foci presence (yes/no)
- Presence of subretinal drusenoid deposits (SDD) (yes/no)
- Loss of outer retinal layers (retinal pigment epithelium, ellipsoid zone) (scale, mm2)
- Fluid (intraretinal fluid, subretinal fluid, pigment epithelium detachment) (yes/no)
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.

Time frame: 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Ursula Schmidt-Erfurth, MD

CONTACT

[email protected]

014040079310

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study 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

Acronym: PYRENEES

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jun 18, 2024
Registry last updated: Jun 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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