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Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

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ClinicalTrials.gov Identifier: NCT00370409
Recruitment Status : Completed
First Posted : August 31, 2006
Last Update Posted : August 1, 2008
Sponsor:
Information provided by:
Shahid Beheshti University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Late Postvitrectomy Diabetic Hemorrhage. Procedure: Cryotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : January 2006
Actual Primary Completion Date : February 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
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.




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

Secondary Outcome Measures :
  1. Incidence of late vitreous hemorrhage in the cryo group. [ Time Frame: 6 months ]
  2. Incidence of late vitreous hemorrhage in the control group. [ Time Frame: 6 months ]
  3. Comparing incidence of late vitreous hemorrhage in both groups. [ Time Frame: 6 months ]


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Ages Eligible for Study:   Child, Adult, Older Adult
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

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

ClinicalTrials.gov Identifier: NCT00370409     History of Changes
Other Study ID Numbers: 8525
First Posted: August 31, 2006    Key Record Dates
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