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Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00370409
First Posted: August 31, 2006
Last Update Posted: August 1, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shahid Beheshti University of Medical Sciences
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University of Medical Sciences:

Primary Outcome Measures:
  • Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • 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 ]

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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370409


Locations
Iran, Islamic Republic of
Ophthalmic Research Center
Tehran, Iran, Islamic Republic of, 16666
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences
Investigators
Principal Investigator: Morteza Entezari, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

ClinicalTrials.gov Identifier: NCT00370409     History of Changes
Other Study ID Numbers: 8525
First Submitted: August 30, 2006
First Posted: August 31, 2006
Last Update Posted: August 1, 2008
Last Verified: July 2008

Keywords provided by Shahid Beheshti University of Medical Sciences:
Rebleeding
Diabetic vitreous hemorrhage
Cryotherapy

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes