ICELAND: Intravitreous CytokinE Level in pAtient With retiNal Detachment

• Sponsor: Central Hospital, Nancy, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT03318588
• Collaborator: (none)
• Enrollment: 74
• Location: 1
• Actual Duration (Months): 10.8
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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	Phase
Retinal Detachment	Procedure: Vitrectomy

Study Design

• 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: Nov 15, 2017
• Actual Primary Completion Date: Jun 28, 2018
• Actual Study Completion Date: Oct 11, 2018

Arms and Interventions

Arm	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

Primary Outcome Measures

1. Intravitreous cytokine levels [up to one month after surgery]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	Brabois Hospital	Vandœuvre-lès-Nancy		France	54500

Sponsors and Collaborators

• Central Hospital, Nancy, France

Investigators

• Principal Investigator: Jean-Baptiste CONART, MD, Brabois Hospital, Department of Ophthalmology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Oct 24, 2017
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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, Medical Doctor, Central Hospital, Nancy, France: Retinal detachment; Photoreceptor apoptosis; Cytokine
• Additional relevant MeSH terms: Retinal Detachment; Dissociative Disorders

Study Results

No Results Posted as of Jul 20, 2022