Late Postvitrectomy Diabetic Hemorrhage. Clinical Trial
| Verified date | July 2008 |
| Source | hahid Beheshti University of Medical Sciences |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Iran: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 112 |
| Est. completion date | June 2008 |
| Est. primary completion date | February 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Iran, Islamic Republic of | Ophthalmic Research Center | Tehran |
| Lead Sponsor | Collaborator |
|---|---|
| hahid Beheshti University of Medical Sciences |
Iran, Islamic Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes | 6 months | No | |
| Secondary | Incidence of late vitreous hemorrhage in the cryo group. | 6 months | No | |
| Secondary | Incidence of late vitreous hemorrhage in the control group. | 6 months | No | |
| Secondary | Comparing incidence of late vitreous hemorrhage in both groups. | 6 months | No |