Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage

Study Overview
=================
Brief Summary
-----------------
The Purpose of this study is compare the efficacy of intravitreal triamcinolone in clearing recurrent post-vitrectomy diabetic hemorrhage with conventional treatment, air-fluid exchange.

Detailed Description
-----------------
Vitreous hemorrhage is the most common complication of vitrectomy for diabetic retinopathy. Despite measures to prevent and control this bleeding, it can lead to air-fluid exchange in the office or to additional surgery in the operating room. Air-fluid exchange does not result in clear vision immediately after the procedure, and the patient has to maintain a face-down position. Vitreous lavage, a more invasive procedure performed in the operating room, may give rise to complications such as iatrogenic retinal breaks, incarcerations of vitreous in the sclerotomy sites, retinal detachment, rubeosis iridis, neovascular glaucoma, infective endophthalmitis, and sympathetic ophthalmia. In contrast, IVT injection as a treatment of post vitrectomy diabetic vitreous hemorrhage is a less invasive procedure and provides more prompt visual recovery, while avoiding the face-down position. We believe that the rapid clearing of vitreous hemorrhage results from as follows: (1) triamcinolone delivered in vitreous cavity can give rise to mechanical sediment entangled with remaining blood (2) direct vascular stabilizing effect may be induced (3) antiangiogenic effect may play a role.

Official Title
-----------------
Comparative,Randomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage

Conditions
-----------------
Post Vitrectomy State, Recurrent Diabetic Vitreous Hemorrhage

Intervention / Treatment
-----------------
* Procedure: Intravitreal triamcinolone injection
* Procedure: Air-fluid exchange


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous vitrectomy due to proliferative diabetic retinopathy Recurrent diabetic vitreous hemorrhage Exclusion Criteria: Monocular vision Uncontrollable intraocular pressure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Intravitreal triamcinolone injection|nan|
|Procedure: Air-fluid exchange|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| day 1 : intraocular pressure, biomicroscope exam, fundus exam |  |  | 
| day 7 : intraocular pressure, biomicroscope exam, fundus exam |  |  | 
| 2 weeks : intraocular pressure, biomicroscope exam, fundus exam |  |  | 
| 4weeks: intraocular pressure, biomicroscope exam, fundus exam, fluorescein angiography |  |  | 
| 2 months : intraocular pressure, biomicroscope exam, fundus exam |  |  | 
| 3months : intraocular pressure, biomicroscope exam, fundus exam |  |  | 
| 6 months : intraocular pressure, biomicroscope exam, fundus exam |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Post vitrectomy, Recurrent diabetic vitreous hemorrhage, Intravitreal triamcinolone injection