Diabetic Retinopathy, Retinal Detachment
Conditions
Keywords
Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Bevacizumab, preoperative, pars plana vitrectomy
Brief summary
The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with and without preoperative intravitreal bevacizumab treatment.
Interventions
DRUGBevacizumab
Intravitreal bevacizumab (1.5 mg; 0,06 ml) 1 week after baseline; pars plana vitrectomy 3 weeks after baseline
PROCEDUREpars plana vitrectomy
pars plana vitrectomy 3 weeks after baseline
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.
Exclusion criteria
* Massive vitreous hemorrhage preventing from detailed posterior pole examination; * Previous intra-ocular surgery other than cataract surgery * Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin * Prothrombin time, partial thromboplastin time or platelet count without normal limits * History of previous thromboembolic events
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| amount of intraoperative intra-ocular bleeding | three weeks |
Countries
Brazil
Outcome results
None listed