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
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Shahid 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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Shahid Beheshti Medical University
Investigators
Principal Investigator: Morteza Entezari, MD Ophthalmic Research Center of Shaheed Beheshti Medical University
  More Information

No publications provided

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

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014