Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347302
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-03-29
Brief Title:
Study of Vitreoretinal Molecular Changes During Rhegmatogenous Retinal Detachment
Sponsor:
Centre Hospitalier Universitaire Dijon
Organization:
Centre Hospitalier Universitaire Dijon
Study Overview
Official Title:
Study of Vitreoretinal Molecular Changes During Rhegmatogenous Retinal Detachment
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIPIDRET
Brief Summary:
Retinal detachment is a condition with an estimated incidence of between 95 and 182 cases per 100000 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None