Short Term Postoperative Tamponade Using Perfluorocarbon... | NCT01604616

Studies
Short Term Postoperative Tamponade Using Perfluorocarbon Liquid for Giant Retinal Tears

NCT01604616

Sponsor

Ziv Hospital

Status

Unknown status

Last Update Posted

May 23, 2012Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Retinal Detachment

Interventions

Not provided

Countries

Israel

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

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1998

Primary Completion Date

Not provided

Completion Date

Jun 2012Estimated

First Submitted Date

May 21, 2012

First Submission Date that Met QC Criteria

May 22, 2012

First Posted Date

May 23, 2012Estimated

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

May 22, 2012

Last Update Posted Date

May 23, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the article is, to investigate the efficacy and safety of perfluorocarbon liquid (PFCL) ,as a short term postoperative tamponade for treating retinal detachment ,associated with giant retinal tears.

Detailed Description

a retrospective study wich compared 2 groups that had giant tear repair in one group, PFCL was left for few days as an intermediate measure until silicone oil or SF6 gas was used to reattach the retina ,and in the control group SF6 or Silicone oil were used, with no PFCL.

Design Module

Study Type

Observational

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 provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PCFL GROUP		patients in this group had the PFCL for a period of 7-10 days before it was replaced by SF6 gas or silicone oil
control group		in thos group no PFCL was left in the eye and either SF6 or silicone oil was the definitive treatment at the time of the retinal detachment surgery repair.

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

above 18 years of age
retinal tear at least of 3 clock hours.

Exclusion Criteria:

less than 18 years of age
Retinal tear less than 3 hours

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

man and women above the age of 18 years

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joseph pikkel, M.D	Ziv Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ziv Medical Center	Recruiting	Safed			Israel

Condition Browse Module

MeSH Terms

ID	Term
D012163	Retinal Detachment

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided