Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

Shahid Beheshti University of Medical Sciences112 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

112

Conditions

Late Postvitrectomy Diabetic Hemorrhage.

Interventions

CryotherapyPROCEDURE

Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Ophthalmic Research Center

Tehran, Tehran Province, Iran

Outcomes

Primary Outcomes

Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes

Time frame: 6 months

Secondary Outcomes

Incidence of late vitreous hemorrhage in the cryo group.

Time frame: 6 months

Incidence of late vitreous hemorrhage in the control group.

Time frame: 6 months

Comparing incidence of late vitreous hemorrhage in both groups.

Time frame: 6 months

Data from ClinicalTrials.gov

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