Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti Medical University
ClinicalTrials.gov Identifier:
NCT00370409
First received: August 30, 2006
Last updated: July 31, 2008
Last verified: July 2008

August 30, 2006
July 31, 2008
January 2006
February 2008   (final data collection date for primary outcome measure)
Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes
Complete list of historical versions of study NCT00370409 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
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Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage
Not Provided

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Late Postvitrectomy Diabetic Hemorrhage.
Procedure: Cryotherapy
Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.
  • Experimental: 1
    Cryotherapy
    Intervention: Procedure: Cryotherapy
  • Placebo Comparator: 2
    Intervention: Procedure: Cryotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
June 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT00370409
8525
Not Provided
Not Provided
Shahid Beheshti Medical University
Not Provided
Principal Investigator: Morteza Entezari, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
Shahid Beheshti Medical University
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP