Vitreous Inflammation in Standard and Heavy Silicone Oil

Università degli Studi di Brescia

Status: Completed

Conditions: Vitreous Inflammation

Treatments: Device: Vitreous Tamponade with Silicone Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02675543

Vitreo002

Details and patient eligibility

About

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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patient scheduled for vitrectomy

Exclusion criteria

• diabetic retinopathy
• uveitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Standard silicone oil

Experimental group

Description:

after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)

Treatment:

Device: Vitreous Tamponade with Silicone Oil

Heavy silicone oil

Experimental group

Description:

after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)

Treatment:

Device: Vitreous Tamponade with Silicone Oil