Efficacy of Subtenon's Block With Olive Tipped Cannula | NCT01019018

Studies
Efficacy of Subtenon's Block With Olive Tipped Cannula

NCT01019018

Sponsor

King Khaled Eye Specialist Hospital

Status

Completed

Last Update Posted

Oct 21, 2021Actual

Enrollment

120Actual

Phase

Phase 4

Conditions

Cataract

Interventions

subtenon block
subtenon block

Countries

Saudi Arabia

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

Nov 2009

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

Nov 2009Actual

Primary Completion Date

Apr 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Nov 17, 2009

First Submission Date that Met QC Criteria

Nov 24, 2009

First Posted Date

Nov 25, 2009Estimated

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

Oct 14, 2021

Last Update Posted Date

Oct 21, 2021Actual

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 this study is to compare the efficacy of olive tip cannula to the standard Steven's cannula in performing subtenon's anesthesia for patients undergoing cataract surgery.

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stevens cannula	Active Comparator	Subtenon with stevens cannula	Device: subtenon block
Olive tip	Experimental	Olive tip group	Device: subtenon block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
subtenon block	Device	subtenon block with stevens cannula	Stevens cannula

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of Akinesia score		10 minutes after the block

Secondary Outcomes

Measure	Description	Time Frame
Surgeon satisfactions score		At the end of the procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patient undergoing cataract extraction procedure under local anesthesia

Exclusion Criteria:

Patients allergic to local anesthetic solutions.
Presence local sepsis,
Previous retinal or strabismus surgery in the same eye.
Orbital abnormalities
Previous subtenon's block in the same quadrant.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
king Khaled Eye Specialist hospital		Riyadh		11462	Saudi Arabia

Condition Browse Module

MeSH Terms

ID	Term
D002386	Cataract

Ancestor Terms

ID	Term
D007905	Lens Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided