- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07682025
Imaging and Predictive Modelling of Proliferative Vitreoretinopathy.
Identification of Imaging Biomarkers and Predictive Modelling of Proliferative Vitreoretinopathy Using Deep Learning.
Patients with retinal detachment are at risk of recurrence and failure of surgery requiring multiple surgeries due to a condition called proliferative vitreoretinopathy (PVR).
Study aims to help tailor patients' treatments and improve outcomes by:
[i] studying imaging biomarkers of PVR, and [ii] develop AI models for PVR detection.
Inclusion:
- Patients with 'complicated' retinal detachment with PVR recruited to a phase 1 dose-finding trial called MORPH-1.
- Patients with 'simple' retinal detachment without PVR recruited to a PhD study.
Non -invasive multimodal imaging and anonymized imaging will be used to study imaging biomarkers of PVR and develop deep learning models to predict PVR in collaboration with an artificial intelligence (AI) expert team at UCL Institute of Ophthalmology.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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London, United Kingdom
- University College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- MORPH-1 and Cohort-NHS study imaging
Exclusion Criteria:
- Participants from above studies who have not consented for image analysis and AI related analysis.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Rhegmatogenous retinal detachment without proliferative vitreoretinopathy
Rhegmatogenous retinal detachment without proliferative vitreoretinopathy at the time of their primary surgery
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Rhegmatogenous retinal detachment with proliferative vitreoretinopathy
Rhegmatogenous retinal detachment with proliferative vitreoretinopathy at the time of their primary surgery or post-operatively with recurrent retinal detachment.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To study multimodal imaging biomarkers of PVR.
Time Frame: Preoperative biomarkers of PVR on cases with established PVR Post-operative biomarkers of PVR on cases that develop PVR in the first 3 months.
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Use multimodal imaging namely widefield Optos, Widefield OCT, OCT macula, OCT disc, OCT EDI and OCTA to describe biomarkers of PVR.
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Preoperative biomarkers of PVR on cases with established PVR Post-operative biomarkers of PVR on cases that develop PVR in the first 3 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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To develop deep learning AI models for PVR detection in retinal detachment.
Time Frame: Post-operative 3 months
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Use widefield Optos imaging and OCT to:
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Post-operative 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James Bainbridge, University College, London
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EDGE 183954
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Proliferative Vitreoretinopathy
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Stanford UniversityWithdrawnProliferative VitreoretinopathyUnited States
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Wills EyeCompletedProliferative VitreoretinopathyUnited States
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Centro Oftalmológico Dr CharlesCompletedProliferative VitreoretinopathyArgentina
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National Eye Institute (NEI)CompletedRetinal Detachment | Proliferative Vitreoretinopathy
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Indonesia UniversityCompletedRhegmatogenous Retinal Detachment | Proliferative VitreoretinopathyIndonesia
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University of Health Sciences LahoreRecruitingProliferative VitreoretinopathyPakistan
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Shanghai 10th People's HospitalUnknown
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Unity Health TorontoRecruitingProliferative Vitreoretinopathy in Rhegmatogenous Retinal DetachmentCanada
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Aldeyra Therapeutics, Inc.CompletedThe GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative VitreoretinopathyProliferative VitreoretinopathyUnited States
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Shahid Beheshti University of Medical SciencesUnknownProliferative VitreoretinopathyIran, Islamic Republic of