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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06347302
Other study ID # EID 2023
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 25, 2024
Est. completion date October 2025

Study information

Verified date March 2024
Source Centre Hospitalier Universitaire Dijon
Contact Petra EID
Phone 0380295173
Email petra.eid@chu-dijon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date October 2025
Est. primary completion date October 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Biological:
Blood sampling
Two tubes will be taken, the first tube (Tube 1) for specialised lipid analysis. The second tube (Tube 2) for routine biochemical analysis
Other:
vitreous sampling
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
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.
Retinal tissue sampling
cutting and aspiration of the retina using the vitreotome opposite the tear to allow access to the sub-retinal fluid.

Locations

Country Name City State
France Chu Dijon Bourgogne Dijon

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 At the time of surgery
See also
  Status Clinical Trial Phase
Terminated NCT02574624 - Vitreous Surgery With Intraocular Assistance N/A