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Trial record 1 of 4 for:    cytokines | retinal detachment
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Intravitreous CytokinE Level in pAtient With retiNal Detachment (ICELAND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03318588
Recruitment Status : Completed
First Posted : October 24, 2017
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Docteur Jean-Baptiste CONART, Central Hospital, Nancy, France

Study Description
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Brief Summary:

Photoreceptor apoptosis is the basis for permanent visual loss in a number of retinal disorders including age-related macular degeneration (AMD) and retinal detachment (RD). Thus, despite tremendous advances in vitreoretinal surgery and management of rhegmatogenous RD leading to a primary reattachment rate over 95%, some patients show poor visual recovery because of photoreceptor apoptosis.

Physiologically, microglial cells (resident macrophages) are present only in the inner retina. The subretinal space, located between the retinal pigment epithelium (RPE) and the photoreceptor outer segments (POS), is devoid of all mononuclear phagocytes and form a zone of immune privilege. In AMD, several studies showed a strong association between subretinal mononuclear phagocytes infiltration and advanced forms of AMD. Experimental work in mice suggest that this infiltration plays an important role in the pathogenesis of this condition by producing inflammatory cytokines.

RD-induced photoreceptor apoptosis might result from similar mechanisms. The aim of this study is to determine the cytokine profile in vitreous samples from patients with RD and to compare it with those from control patients with macular hole.


Condition or disease Intervention/treatment
Retinal Detachment Procedure: Vitrectomy

Study Design
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Study Type : Observational
Actual Enrollment : 74 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Intravitreous CytokinE Level in pAtient With retiNal Detachment
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : June 28, 2018
Actual Study Completion Date : October 11, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Case
Patients undergoing vitrectomy for primary retinal detachment
 Procedure: Vitrectomy
Pars plana vitrectomy
Control
Patients undergoing vitrectomy for idiopathic macular hole
 Procedure: Vitrectomy
Pars plana vitrectomy


Outcome Measures
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Primary Outcome Measures :
  1. Intravitreous cytokine levels [ Time Frame: up to one month after surgery ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Patients from the department of Ophthalmology (Nancy University Hospital)
Criteria

Inclusion Criteria:

  • Patients with primary retinal detachment requiring vitrectomy
  • Patients with idiopathic macular hole requiring vitrectomy

Exclusion Criteria:

  • History of retinal detachment or intraocular inflammatory diseases
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318588


Locations
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France
Brabois Hospital
Vandœuvre-lès-Nancy, France, 54500
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
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Principal Investigator: Jean-Baptiste CONART, MD Brabois Hospital, Department of Ophthalmology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Docteur Jean-Baptiste CONART, Medical Doctor, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03318588    
Other Study ID Numbers: 2017-A02195-48
First Posted: October 24, 2017    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Docteur Jean-Baptiste CONART, Central Hospital, Nancy, France:
Retinal detachment
Photoreceptor apoptosis
Cytokine
Additional relevant MeSH terms:
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Retinal Detachment
Dissociative Disorders
Mental Disorders
Retinal Diseases
Eye Diseases