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

Not yet recruiting

• Conditions: Age-Related Macular Degeneration

• Registration Number: NCT06465212
• Lead Sponsor: Medical University of Vienna

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-13
• Study First Submitted QC: 2024-06-13
• Study First Posted: 2024-06-18
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-21
• Study Start: 2024-07
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of different AMD stages on OCT images from a community-based setting to calculate the real-world prevalence of AMD	2 years	AMD 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 Outcome Measures

Name	Time	Method
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
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 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)