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Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

Primary Purpose

Late Postvitrectomy Diabetic Hemorrhage.

Status

Completed

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Cryotherapy

About this trial

This is an interventional prevention trial for Late Postvitrectomy Diabetic Hemorrhage. focused on measuring Rebleeding, Diabetic vitreous hemorrhage, Cryotherapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Ophthalmic Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Cryotherapy

Outcomes

Primary Outcome Measures

Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes

Secondary Outcome Measures

Incidence of late vitreous hemorrhage in the cryo group.

Incidence of late vitreous hemorrhage in the control group.

Comparing incidence of late vitreous hemorrhage in both groups.

Full Information

NCT ID

NCT00370409

First Posted

August 30, 2006

Last Updated

July 31, 2008

Sponsor

Shahid Beheshti University of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00370409

Brief Title

Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

Study Type

Interventional

2. Study Status

Record Verification Date

July 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

February 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Shahid Beheshti University of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Late Postvitrectomy Diabetic Hemorrhage.

Keywords

Rebleeding, Diabetic vitreous hemorrhage, Cryotherapy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

112 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Cryotherapy

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Procedure

Intervention Name(s)

Cryotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Incidence of late vitreous hemorrhage in the cryo group.

Time Frame

6 months

Title

Incidence of late vitreous hemorrhage in the control group.

Time Frame

6 months

Title

Comparing incidence of late vitreous hemorrhage in both groups.

Time Frame

6 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Morteza Entezari, MD

Organizational Affiliation

Ophthalmic Research Center of Shaheed Beheshti Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmic Research Center

City

Tehran

ZIP/Postal Code

16666

Country

Iran, Islamic Republic of

12. IPD Sharing Statement

Learn more about this trial

Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

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