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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06465212
Acronym
PYRENEES
Enrollment
5000
Registered
2024-06-18
Start date
2024-07-31
Completion date
2026-07-31
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

Keywords

Telemedicine, Ophthalmic Coherence Tomography, Shared-care

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

Interventions

DEVICETopCon Maestro 2 OCT

Ophthalmic Coherence Tomography

Sponsors

Medical University of Vienna
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
55 Years to 99 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Identification of different AMD stages on OCT images from a community-based setting to calculate the real-world prevalence of AMD2 yearsAMD staging will be carried out by a certified ophthalmologist at the Medical University of Vienna according to the following parameters: 1. Healthy aging retina, including drupelets \< 63 µm \[3\] 2. Early AMD as defined in the protocol \[3\] (see 7.3 disease definitions): Medium drusen \>63 µm and \>125 µm. No AMD pigmentary abnormalities. 3. Intermediate AMD as defined in the protocol \[3\] (see 7.3 disease definitions): Large druse \> 125 µm and/or and pigmentary abnormalities 4. Late AMD: Geographic Atrophy as defined in the protocol \[3,6\] (see 7.3 disease definitions) 5. Other diseases: including neovascular AMD, RVO, DME, CCS, Stargardt disease, Pattern dystrophy, etc.

Secondary

MeasureTime frameDescription
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.2 yearsBiomarkers 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.2 years

Contacts

Primary ContactUrsula Schmidt-Erfurth, MD
ursula.schmidt-erfurth@meduniwien.ac.at014040079310

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026