Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage - Full Text View

Sponsored by:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00370409

Purpose

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.

Condition	Intervention
Late Postvitrectomy Diabetic Hemorrhage.	Procedure: Cryotherapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of late vitreous hemorrhage in the cryo group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Incidence of late vitreous hemorrhage in the control group. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Comparing incidence of late vitreous hemorrhage in both groups. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Enrollment:	112
Study Start Date:	January 2006
Study Completion Date:	June 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Cryotherapy	Procedure: Cryotherapy Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.
2: Placebo Comparator	Procedure: Cryotherapy Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370409

Locations

Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666

Sponsors and Collaborators

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Morteza Entezari, MD

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

Study ID Numbers:	8525
Study First Received:	August 30, 2006
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00370409
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

Rebleeding
Diabetic vitreous hemorrhage
Cryotherapy

Study placed in the following topic categories:

Hemorrhage
Vitreous Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009