Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage
Not Applicable
Completed
- Conditions
- Late Postvitrectomy Diabetic Hemorrhage.
- Interventions
- Procedure: Cryotherapy
- Registration Number
- NCT00370409
- Lead Sponsor
- Shahid Beheshti University of Medical Sciences
- Brief Summary
Late vitreous hemorrhage in postvitrectomized diabetic eyes may be due to fibrovascular tuft formation in sclerotomy sites. Cryotherapy of sclerotomy sites may prevent bleeding by regressing the fibrovascular tuft. This study will detect the safety and efficacy of cryotherapy of sclerotomy sites for prevention of late vitreous hemorrhage in vitrectomized diabetic eyes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 112
Inclusion Criteria
- Diabetic retinopathy cases undergoing vitrectomy
Exclusion Criteria
- History of deep vitrectomy or cataract surgery
- Renal failure
- Silicone oil injection during surgery
- Early rebleeding
- History of antithrombotic drugs usage
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Cryotherapy Cryotherapy 2 Cryotherapy -
- Primary Outcome Measures
Name Time Method Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes 6 months
- Secondary Outcome Measures
Name Time Method Incidence of late vitreous hemorrhage in the cryo group. 6 months Incidence of late vitreous hemorrhage in the control group. 6 months Comparing incidence of late vitreous hemorrhage in both groups. 6 months
Trial Locations
- Locations (1)
Ophthalmic Research Center
🇮🇷Tehran, Iran, Islamic Republic of