Study of Imaging and Molecular Biomarkers in Uncomplicated Rhegmatogenous Retinal Detachment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Retinal Detachment Rhegmatogenous, Proliferative Vitreoretinopathy, Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Disease or general study area: Uncomplicated rhegmatogenous retinal detachment (RRD) and risk of proliferative vittroretinopathy (PVR) Purpose and nature of the study: 1. Characterise the cytokine profile of vitreous fluid in uncomplicated RRD. 2. Develop a risk model to predict development of PVR after retinal detachment surgery using imaging and molecular biomarkers. 3. 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.
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:
1. Characterise the cytokine profile of vitreous fluid in uncomplicated RRD. 2. Develop a risk model to predict development of PVR after retinal detachment surgery using imaging and molecular biomarkers. 3. 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.
Primary outcome measures
- Characterise the cytokine milieu in an uncomplicated RRD eye. [Time frame: 3 months]
Secondary outcome measures (2)
- Develop a risk model for development of PVR after retinal detachment surgery using imaging and molecular biomarkers. [Time frame: 3 months]
- To develop deep learning AI models for PVR detection in retinal detachment. [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Moorfields Eye Hospital — London
Identifiers
NCT: NCT07386678 · EDGE 179423