Late Postvitrectomy Diabetic Hemorrhage.
Conditions
Keywords
Rebleeding, Diabetic vitreous hemorrhage, Cryotherapy
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.
Interventions
PROCEDURECryotherapy
Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.
Sponsors
Shahid Beheshti University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Iran
Outcome results
None listed