Post Vitrectomy State Clinical Trial
Official title:
Comparative,Randomized Study Between Intravitreal Triamcinolone Acetonide and Air-Fluid Exchange in Eyes With Post Vitrectomy Diabetic Vitreous Hemorrhage
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment