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

Age-Related Macular Degeneration Clinical Trial

— PYRENEES  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465212
• Other study ID #: 1318/2024
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: July 2026

Study information

• Verified date: June 2024
• Source: Medical University of Vienna
• Contact: Ursula Schmidt-Erfurth, MD
• Phone: 014040079310
• Email: ursula.schmidt-erfurth[@]meduniwien.ac.at
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 5000
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Device:
• TopCon Maestro 2 OCT
Ophthalmic Coherence Tomography

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of different AMD stages on OCT images from a community-based setting to calculate the real-world prevalence of AMD	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.	2 years
Secondary	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.	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)	2 years
Secondary	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