Age-Related Macular DegenerationPYRENEESNCT06465212
Personalized Shared Eye-care Identification of Age-related Macular Degeneration Using Artificial Intelligence and Telemedicine by Matching Optometrist Office-based Sites With Clinical Supervision
An observational study of Age-Related Macular Degeneration, run by Medical University of Vienna.
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… Read more about this study
- Who is it for?
- Ages 55 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- TopCon Maestro 2 OCT
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2024to Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age: 55-99 years old
- Preserved visual function, defined as visual acuity better than or equal to 0.3logMAR in one or both eyes
Who cannot join
- Refractive errors with mean spherical equivalent (MSE) greater than +/-6.00, with no limit to astigmatic component.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read more
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
- Being tested
- TopCon Maestro 2 OCT
- Keywords
- Telemedicine, Ophthalmic Coherence Tomography, Shared-care
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TopCon Maestro 2 OCTDevice
Ophthalmic Coherence Tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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)
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study startJul 2024 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ursula Schmidt-Erfurth, M.D., Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465212
- Sponsor's protocol ID
- 1318/2024
- Acronym
- PYRENEES
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06465212
- Acronym / sponsor ID
- PYRENEES / 1318/2024
- Conditions
- Age-Related Macular Degeneration
- Keywords
- Telemedicine, Ophthalmic Coherence Tomography, Shared-care
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Age: 55-99 years old
- Preserved visual function, defined as visual acuity better than or equal to 0.3logMAR in one or both eyes
Key exclusion criteria (1 listed)
- Refractive errors with mean spherical equivalent (MSE) greater than +/-6.00, with no limit to astigmatic component.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TopCon Maestro 2 OCTOphthalmic Coherence Tomography | Device | – |
Primary outcome
Identification of different AMD stages on OCT images from a community-based setting to calculate the real-world prevalence of AMD
Time frame: 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.
2 secondary outcomes
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.
Time frame: 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.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Related trials for Age-Related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ursula Schmidt-Erfurth, MD (014040079310, ursula.schmidt-erfurth@meduniwien.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of different AMD stages on OCT images from a community-based setting to calculate the real-world prevalence of AMD (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.