Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

Sponsor

Shahid Beheshti University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00370409

Collaborator

(none)

112

Enrollment

Location

Arms

Duration (Months)

3.9

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

112 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Prevention

Study Start Date :

Jan 1, 2006

Actual Primary Completion Date :

Feb 1, 2008

Actual Study Completion Date :

Jun 1, 2008

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes [6 months]

Secondary Outcome Measures

Incidence of late vitreous hemorrhage in the cryo group. [6 months]
Incidence of late vitreous hemorrhage in the control group. [6 months]
Comparing incidence of late vitreous hemorrhage in both groups. [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00370409

Other Study ID Numbers:

8525

First Posted:

Aug 31, 2006

Last Update Posted:

Aug 1, 2008

Last Verified:

Jul 1, 2008

Keywords provided by , ,

Rebleeding

Diabetic vitreous hemorrhage

Cryotherapy

Additional relevant MeSH terms:

Hemorrhage

Study Results

No Results Posted as of Aug 1, 2008