- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07386678
Study of Imaging and Molecular Biomarkers in Uncomplicated Rhegmatogenous Retinal Detachment (Cohort-NHS)
Disease or general study area: Uncomplicated rhegmatogenous retinal detachment (RRD) and risk of proliferative vittroretinopathy (PVR)
Purpose and nature of the study:
- Characterise the cytokine profile of vitreous fluid in uncomplicated RRD.
- Develop a risk model to predict development of PVR after retinal detachment surgery using imaging and molecular biomarkers.
- To develop deep learning/artificial intelligence (AI) models for PVR detection in retinal detachment.
Inclusion criteria:
50 adult ( ≥18 years) patients with uncomplicated rhegmatogenous retinal detachments without PVR.
What participating will involve:
Pre- and post-operative assessments and intervention will follow standard of care for patients with rhegmatogenous retinal detachments.
Additional intervention will include non-invasive imaging of anterior chamber flare, vitreous, wide-field retina, macula optical coherence tomography (OCT) and macula OCT-angiography (OCT-A) as well as, seeking participant's consent on collecting their vitreous fluid at time of their surgery for cytokine analysis.
Study Overview
Status
Detailed Description
This is an observational cohort study of 50 participants with uncomplicated rhegmatogenous retinal detachment. Participants will have their vitreous fluid collected at the time of surgery for cross-sectional analysis of cytokine milieu and a series of pre-operative and post-operative non-invasive imaging over 3 months. Unfortunately, 15-20% of the patients with primary retinal detachment will have recurrent retinal detachments following surgery secondary to an anomalous scarring process called proliferative vitreoretinopathy (PVR).
Therefore, aims of this study are to:
- Characterise the cytokine profile of vitreous fluid in uncomplicated RRD.
- Develop a risk model to predict development of PVR after retinal detachment surgery using imaging and molecular biomarkers.
- To develop deep learning/artificial intelligence (AI) models for PVR detection in retinal detachment.
Above will guide future treatments for PVR and further identify high risk populations not just from a clinical perspective but with the utilisation of their imaging and molecular biomarkers.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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London, United Kingdom, N17 9GZ
- Moorfields Eye Hospital
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Contact:
- Achini K
- Phone Number: 07951650070
- Email: a.makuloluwa@nhs.net
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Contact:
- James Bainbridge
- Email: j.bainbridge@ucl.ac.uk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Adults ≥18 years
- Uncomplicated primary rhegmatogenous retinal detachment
- Moorfields Eye Hospital
Description
Inclusion Criteria:
- Adults ≥18 years
- Uncomplicated primary rhegmatogenous retinal detachment
- PVD present
- No PVR-A/B/C
- Phakic or pseudophakic.
Exclusion Criteria:
- Patients <18 years
- Patients lacking capacity
- Previous vitrectomy
- Previous cryopexy
- Aphakia
- No fundal view
- Diabetic retinopathy of any severity
- Retinal detachment secondary to infective causes e.g. acute retinal necrosis, toxoplasmosis scars
- Retinal detachment secondary to congenital defects e.g. optic disc pit/coloboma
- Exudative retinal detachment
- Tractional retinal detachment
- Ongoing involvement in another ocular trial.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Characterise the cytokine milieu in an uncomplicated RRD eye.
Time Frame: 3 months
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Study cytokine profile using a multiplex assay that includes all relevant cytokines.
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Develop a risk model for development of PVR after retinal detachment surgery using imaging and molecular biomarkers.
Time Frame: 3 months
|
Study demographics, existing and novel risk factors from imaging aqueous, vitreous, retinal vasculature and retinal structure, and cytokine molecular biology.
Use a risk model for risk-stratification of patients who develop PVR re detachment.
|
3 months
|
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To develop deep learning AI models for PVR detection in retinal detachment.
Time Frame: 3 months
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Using ultra-widefield retinal imaging and optical coherence tomography in human retinal detachment models.
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3 months
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Collaborators and Investigators
Sponsor
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 179423
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
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.
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