- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06347302
Study of Vitreoretinal Molecular Changes During Rhegmatogenous Retinal Detachment (LIPIDRET)
Retinal detachment is a condition with an estimated incidence of between 9.5 and 18.2 cases per 100,000 individuals.
It is an ophthalmological emergency that threatens visual acuity and requires surgery. However, despite satisfactory post-operative anatomical results, vitreoretinal proliferation and photoreceptor death can still have a negative impact on visual prognosis. These complications are still not fully understood.
A previous study carried out by the Eye, Nutrition and Cell Signalling team at the CSGA, comparing mouse models of retinal detachment with healthy control retinas, revealed an increase in pro-inflammatory cytokines and a change in retinal lipid abundance in detached retinas.
However, these results have yet to be confirmed in humans. Our main hypothesis is that the vitreous content of omega-3 PUFAs and proteins is altered during the onset of retinal detachment, since it reflects both intraocular inflammation and photoreceptor apoptosis.
We therefore wish to demonstrate that the protein and PUFA contents of the vitreous humour are different between eyes with retinal detachment and eyes not affected by retinal detachment after macular surgery (epiretinal membrane or macular hole). We would like to show that the vitreous PUFA content is lower in the macular surgery group due to the absence of photoreceptor apoptosis and the absence of dehiscence causing communication between the subretinal space (photoreceptors whose membranes are very rich in PUFAs) and the vitreous space. We also hope to identify changes in the protein composition of vitreous fluid in patients with retinal detachment, with overexpression of proteins involved in inflammation pathways.
In addition, we hypothesise that retinal omega-3 PUFA content is a factor influencing retino-vitreal proliferation and functional and anatomical recovery from retinal detachment. To this end, we will study the correlation between retinal PUFA-3 content and the clinical presentation and postoperative course of retinal detachment.
Finally, with the aim of identifying a serum marker for the prognostic evaluation of retinal detachment, we will use as a candidate a biomarker of retinal omega-3 PUFA content that we have developed in an Age-Related Macular Degeneration (AMD) model. We will analyse the correlation between this biomarker and levels of omega-3 PUFAs measured directly in the retina.
To do this, we will analyse intraoperative samples of vitreous humour, sub-retinal fluid and retinal fluid from patients undergoing vitrectomy for retinal detachment in the Ophthalmology Department of the Dijon University Hospital. A group of control patients will consist of patients operated on by vitrectomy for macular surgery (epiretinal membrane or macular hole) for whom a vitreous humour sample will also be taken.
Clinical information on the characteristics of the retinal detachment will be collected. During the consultation, the patient will be questioned about any history of dyslipidaemia and any current treatment, including the use of lipid-enriched food supplements. Post-operative follow-up with prospective collection of clinical and paraclinical data on anatomical and functional evolution will be carried out up to 6 months after the occurrence of retinal detachment.
A blood sample will be taken to establish a lipid profile in all patients. We will thus gain a better understanding of the changes in lipid and protein content in the vitreous humour, sub-retinal fluid and retina, and the demonstration of a link between the initial presentation and the postoperative anatomical and functional evolution of retinal detachment. This will provide a better understanding of the lipid-dependent mechanisms linked to inflammation and photoreceptor degeneration during retinal detachment, and will ultimately make it possible to develop new therapeutic strategies to improve visual prognosis.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Dijon, France, 21000
- Chu Dijon Bourgogne
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Subject having given oral, free and informed consent to take part in the study
- Subjects with primary retinal detachment requiring vitrectomy (RD group) Or
- Subject requiring vitrectomy for macular surgery (primary epiretinal membrane or macular hole) (Control group)
Exclusion Criteria:
- Subject not affiliated to or not benefiting from national health insurance
- Pregnant, parturient or breast-feeding women
- Minors
- Subject to a measure of legal protection (curatorship, guardianship)
- Subjects of full age who are incapable or unable to express their consent
- Subject who has already participated in the study
- Subject with recurrent retinal detachment
- Subjects with an epiretinal membrane of secondary origin (OVCR, inflammation, diabetic retinopathy)
- Subject refusing blood sampling
- Subjects with pre-existing retinal pathology (vascular or degenerative retinopathy)
- People with diabetes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Control group
|
Two tubes will be taken, the first tube (Tube 1) for specialised lipid analysis.
The second tube (Tube 2) for routine biochemical analysis
Intra-operative vitreous sampling: systematic collection of the vitreous humour during vitrectomy for vitreoretinal surgery such as retinal detachment, epiretinal membranes and macular holes.
|
|
Active Comparator: Retinal detachment Group
|
Two tubes will be taken, the first tube (Tube 1) for specialised lipid analysis.
The second tube (Tube 2) for routine biochemical analysis
Intra-operative vitreous sampling: systematic collection of the vitreous humour during vitrectomy for vitreoretinal surgery such as retinal detachment, epiretinal membranes and macular holes.
Sub-retinal fluid sampling consists of collecting the sub-retinal fluid that is systematically aspirated during retinal detachment surgery in order to dry the detached retina and allow retinopexy to be performed.
cutting and aspiration of the retina using the vitreotome opposite the tear to allow access to the sub-retinal fluid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Molecular content of fatty acids and proteins in the vitreous humour of eyes operated on for retinal detachment and eyes operated on for macular surgery
Time Frame: At the time of surgery
|
At the time of surgery
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- EID 2023
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 Rhegmatogenous Retinal Detachments
-
Johns Hopkins UniversityTerminatedDislocated Intraocular Lens | Traction Retinal Detachments | Rhegmatogenous Retinal DetachmentsUnited States
-
University College, LondonNot yet recruitingProliferative Vitreoretinopathy | Retinal Detachment Rhegmatogenous | Proliferative Vitreoretinopathy in Rhegmatogenous Retinal DetachmentUnited Kingdom
-
Minia UniversityRecruitingRhegmatogenous Retinal DetachmentEgypt
-
Eye & ENT Hospital of Fudan UniversityRecruiting
-
Eye & ENT Hospital of Fudan UniversityNot yet recruitingRhegmatogenous Retinal DetachmentChina
-
Ain Shams UniversityNot yet recruitingRhegmatogenous Retinal Detachment
-
Sohag UniversityRecruiting
-
The S.N. Fyodorov Eye Microsurgery State InstitutionUnknownRhegmatogenous Retinal DetachmentRussian Federation
-
Meir Medical CenterUnknownRhegmatogenous Retinal DetachmentIsrael
-
University of Campinas, BrazilCompletedRhegmatogenous Retinal Detachment
Clinical Trials on Blood sampling
-
Institut du Cancer de Montpellier - Val d'AurelleRecruitingGlioma | Sarcoma | Cancer | Breast Cancer | Colon Cancer | Lung CancersFrance
-
Medical University of GrazJoanneum Research Forschungsgesellschaft mbHCompleted
-
CardioRenalCompletedPotassium MeasurementBelgium
-
Assistance Publique - Hôpitaux de ParisURC Necker Cochin, FranceCompletedSepsis | Acute Circulatory FailureFrance
-
Fondazione Policlinico Universitario Agostino Gemelli...Active, not recruiting
-
Centre Hospitalier Universitaire DijonCompletedPatients With Intellectual Disabilities Without an Obvious Clinical Diagnosis | Patients With Normal Array CGH and Previous Negative Genetic Investigations (WES-solo or WES-trio)France
-
Royal Surrey County Hospital NHS Foundation TrustCompletedThyroid Carcinoma | Thyroid Cancer | Cancer of the Thyroid | Cancer of ThyroidUnited Kingdom
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Rennes University HospitalCompletedMultiple SclerosisFrance
-
Institut PasteurSanofi Pasteur, a Sanofi Company; Institut Pasteur of Cote d'IvoireCompletedBordetella Pertussis, Whooping CoughCôte D'Ivoire