Vitreous Inflammation in Standard and Heavy Silicone Oil

Vitreous Inflammation Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02675543
• Other study ID #: Vitreo002
• Status: Completed
• Phase: N/A
• First received: January 25, 2016
• Last updated: April 12, 2016
• Start date: June 2015

Study information

• Verified date: April 2016
• Source: Università degli Studi di Brescia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ethics Committee: Italy
• Study type: Interventional

Clinical Trial Summary

The inflammatory response after prolonged retinal detachment and after vitreoretinal surgery has its apex in the development of PVR that occurs when retinal cells are exposed to the inflammatory milieu in the humor vitreous.

This situation is common in complicated retinal detachment, but is amplified after invasive surgery and by the use of intraocular tamponades that float over a subtle film of liquid where the inflammatory cytokines and growth factors reach the critical concentration over the inferior retina.

Many authors have noted that the heavy tamponade are more prone to cause intraocular inflammation compared to standard silicone oil, especially if they remain for several months in the eye.

The purpose of this study is to measure the vitreous concentration of some of the most important cytokines involved in the inflammatory vitreal response.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patient scheduled for vitrectomy

Exclusion Criteria:

• diabetic retinopathy

• uveitis

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Inflammation
• Vitreous Inflammation

Intervention

Device:
• Vitreous Tamponade with Silicone Oil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Università degli Studi di Brescia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitreous Prostaglandin E2 Levels		intraoperarive	No