Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

Shahid Beheshti University of Medical Sciences

Status: Completed

Conditions: Late Postvitrectomy Diabetic Hemorrhage.

Treatments: Procedure: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00370409

8525

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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112 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

Cryotherapy

Treatment:

Procedure: Cryotherapy

2

Placebo Comparator group

Treatment:

Procedure: Cryotherapy