Study of Vitreoretinal Molecular Changes During Rhegmatogenous Retinal Detachment

NCT06347302 | Completed

• 1 other identifier: EID 2023
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhegmatogenous Retinal Detachments

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Retinal detachment Group

ACTIVE COMPARATOR

Biological: Blood sampling; Other: vitreous sampling; Other: Sub-retinal fluid sampling; Other: Retinal tissue sampling

Control group

PLACEBO COMPARATOR

Biological: Blood sampling; Other: vitreous sampling

Interventions

Blood sampling BIOLOGICAL

Two tubes will be taken, the first tube (Tube 1) for specialised lipid analysis. The second tube (Tube 2) for routine biochemical analysis

Control group; Retinal detachment Group

vitreous sampling OTHER

Intra-operative vitreous sampling: systematic collection of the vitreous humour during vitrectomy for vitreoretinal surgery such as retinal detachment, epiretinal membranes and macular holes.

Control group; Retinal detachment Group

Sub-retinal fluid sampling OTHER

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 detachment Group

Retinal tissue sampling OTHER

cutting and aspiration of the retina using the vitreotome opposite the tear to allow access to the sub-retinal fluid.

Retinal detachment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu Dijon Bourgogne

Dijon, 21000, France

Location

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 4, 2024
• Study Start: April 25, 2024
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

FR (1)