Cryotherapy of Sclerotomy Sites for Prevention of Late Po... | NCT00370409

Studies
Cryotherapy of Sclerotomy Sites for Prevention of Late Postvitrectomy Diabetic Hemorrhage

NCT00370409

Sponsor

Shahid Beheshti University of Medical Sciences

Status

Completed

Last Update Posted

Aug 1, 2008Estimated

Enrollment

112Actual

Phase

Not Applicable

Conditions

Late Postvitrectomy Diabetic Hemorrhage.

Interventions

Cryotherapy

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Feb 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Aug 30, 2006

First Submission Date that Met QC Criteria

Aug 30, 2006

First Posted Date

Aug 31, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 31, 2008

Last Update Posted Date

Aug 1, 2008Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

112Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Cryotherapy	Procedure: Cryotherapy
2	Placebo Comparator		Procedure: Cryotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cryotherapy	Procedure	Cryotherapy of both sides of sclerotomy sites was done for 6 seconds after complition of operation.	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevention of late vitreous hemorrhage in postvitrectomized diabetic eyes		6 months

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morteza Entezari, MD	Ophthalmic Research Center of Shaheed Beheshti Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ophthalmic Research Center		Tehran	Tehran Province	16666	Iran