Diabetic Retinopathy, Retinal Detachment
Conditions
Keywords
Diabetic Retinopathy, Retinal detachment, Vitreous Hemorrhage, Preoperative Ranibizumab, pars plana vitrectomy
Brief summary
The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.
Interventions
DRUGRanibizumab
Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy
OTHERSham injection
Simulation of intravitreal injection one week before pars plana vitrectomy
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
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 | Description |
|---|---|---|
| amount of intraoperative intra-ocular bleeding | one week | amount of intra-ocular bleeding that occurred during pars plana vitrectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| visual acuity | 12 weeks | ETDRS best corrected visual acuity at 12 weeks after pars plana vitrectomy |
Countries
Brazil
Outcome results
None listed