Vitreous Inflammation in Standard and Heavy Silicone Oil

NCT ID: NCT02675543

Last Updated: 2017-06-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vitreous Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard silicone oil

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

Group Type EXPERIMENTAL

Vitreous Tamponade with Silicone Oil

Intervention Type DEVICE

Heavy silicone oil

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

Group Type EXPERIMENTAL

Vitreous Tamponade with Silicone Oil

Intervention Type DEVICE

Interventions

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Vitreous Tamponade with Silicone Oil

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patient scheduled for vitrectomy

Exclusion Criteria

* diabetic retinopathy
* uveitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università degli Studi di Brescia

OTHER

Sponsor Role lead

Responsible Party

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Francesco Semeraro

To Compare Vitreous Inflammation in Standard Versus Heavy Silicone Oil

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.

Reference Type DERIVED
PMID: 32408387 (View on PubMed)

Other Identifiers

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Vitreo002

Identifier Type: -

Identifier Source: org_study_id

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