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

NCT06465212 | Not Yet Recruiting DMC

• 1 other identifier: 1318/2024
• Study Type: observational
• Target: 5,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Age-Related Macular Degeneration

Keywords

Telemedicine; Ophthalmic Coherence Tomography; Shared-care

Outcome Measures

Primary Outcomes (1)

• 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: 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.

  2 years

Secondary Outcomes (2)

• 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

• 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

Interventions

TopCon Maestro 2 OCT DEVICE

Ophthalmic Coherence Tomography

Eligibility Criteria

• Age: 55 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Allcomers at the optometrist office that meet the inclusion criteria. In general, there is no specific targeting in recruitment. This collection of data does not represent a traditional clinical study that is recruiting patients, but is exclusively collecting images from asymptomatic individuals. Individuals are imaged within the practice routine of optometrists/opticians. If, in this consecutive series, an individual meets the inclusion criteria for the study, the image is uploaded to the platform. A board-certified ophthalmologist at the Medical University of Vienna then systematically checks all images individually and informs the optometrist about the need for local ophthalmologist referral.

You may qualify if:

• Age: 55-99 years old
• Preserved visual function, defined as visual acuity better than or equal to 0.3logMAR in one or both eyes

You may not qualify if:

• Refractive errors with mean spherical equivalent (MSE) greater than +/-6.00, with no limit to astigmatic component.

Sponsors & Collaborators

• Medical University of Vienna: lead

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Ursula Schmidt-Erfurth, MD

CONTACT

014040079310; ursula.schmidt-erfurth@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06