Clinical trial NCT00300014: Efficacy and Safety of Intravitreal Triamcinolone Acetonide in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
Official title: Comparative,Randomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Vitrectomy State
Recurrent Diabetic Vitreous Hemorrhage
Keywords: Post vitrectomy
Recurrent diabetic vitreous hemorrhage
Intravitreal triamcinolone injection
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2006-03-08
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Previous vitrectomy due to proliferative diabetic retinopathy
* Recurrent diabetic vitreous hemorrhage

Exclusion Criteria:

* Monocular vision
* Uncontrollable intraocular pressure

Primary outcomes:
measure: day 1 : intraocular pressure, biomicroscope exam, fundus exam
measure: day 7 : intraocular pressure, biomicroscope exam, fundus exam
measure: 2 weeks : intraocular pressure, biomicroscope exam, fundus exam
measure: 4weeks: intraocular pressure, biomicroscope exam, fundus exam, fluorescein angiography
measure: 2 months : intraocular pressure, biomicroscope exam, fundus exam
measure: 3months : intraocular pressure, biomicroscope exam, fundus exam
measure: 6 months : intraocular pressure, biomicroscope exam, fundus exam
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Sun Young Lee, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: He Won Chung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Young Hee Yoon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: June-Gone Kim, MD
role: PRINCIPAL_INVESTIGATOR
References: