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

NCT ID: NCT06465212

Last Updated: 2024-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-07-31

Study Completion Date

2026-07-31

Brief Summary

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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

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Conditions

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Age-Related Macular Degeneration

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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TopCon Maestro 2 OCT

Ophthalmic Coherence Tomography

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Ursula Schmidt-Erfurth, M.D.

Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Ursula Schmidt-Erfurth, MD

Role: CONTACT

014040079310

Other Identifiers

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1318/2024

Identifier Type: -

Identifier Source: org_study_id

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