Intravitreal Injection Anesthesia - Comparison of Differe... | NCT01224847

Studies
Intravitreal Injection Anesthesia - Comparison of Different Topical Agents

NCT01224847

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Completed

Last Update Posted

Apr 19, 2012Estimated

Enrollment

92Actual

Phase

Not Applicable

Conditions

Age-Related Macular Degeneration (AMD)

Interventions

Tetracaine
Cocaine
Lidocaine

Countries

Canada

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

ID	Type	Description	Link
16454	Other Identifier	REB

Status Module

Record Verification Date

Apr 2012

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

Oct 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Oct 6, 2010

First Submission Date that Met QC Criteria

Oct 19, 2010

First Posted Date

Oct 20, 2010Estimated

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

Apr 17, 2012

Last Update Posted Date

Apr 19, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thomas G. Sheidow, MD, FRCSC, Ophthalmologist, Vitreoretinal Surgeon, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sPrincipal Investigator

Lead Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Patients with neovascular age-related macular degeneration (AMD) scheduled to receive intravitreal (IVT) Ranibizumab injection will be randomized to receive one of three topical anesthetics: (1) tetracaine drop (gtt) + lidocaine pledget to the injection site for 10 seconds (2) tetracaine gtt alone and (3) cocaine gtt alone. A questionnaire will be conducted immediately after and 15 minutes after the injection, to assess for pain.

Detailed Description

All patients scheduled to receive intravitreal Ranibizumab for the treatment of neovascular AMD will be evaluated for inclusion into the study. After a positive evaluation, the study will be explained to the patient, the Letter of Explanation reviewed with the patient and informed consent approved if patient agrees to participate. Demographic data of sex and age will be recorded. As well the number of previous intravitreal injections will be recorded ( none, 2 - 5 and > 5 ). A nurse will then proceed to select an opaque envelope from a box of identical envelopes. The envelope will contain the topical anesthetic agent to be used. The randomization code linking each patient to their anesthetic will be stored in a secure location, and only accessed at the completion of the trial. The anesthetic procedure will be performed by someone other than the surgeon who will perform the IVT injection. After a minute of the anesthetic application, the surgeon, blinded to the anesthetic intervention, will perform the IVT injection of Ranibizumab. Immediately following the injection, a blinded observer will first explain the Pain Questionnaire, and then conduct it. Also at this time, the physician who performed the injection will complete the Wong-Baker Pain Questionnaire. The patient will then be asked to wait in a room for an additional 15 minutes, where the same observer will return and the Pain Questionnaire will be conducted a second time.

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

92Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tetracaine gtt	Active Comparator	Pre-Intravitreal injection - 1 gtt Tetracaine topically	Drug: Tetracaine
Tetraciane gtt + Lidocaine pledget	Active Comparator	1 gtt Tetracaine pre-IVT injection + application Lidocaine pledget to injection site	Drug: Lidocaine
Cocaine gtt alone	Active Comparator	1 gtt pre-IVT injection	Drug: Cocaine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tetracaine	Drug	1 gtt	Tetracaine gtt
Cocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To elucidate the most effective topical agent for intravitreal injections.	Patients will measure pain by the use of a Visual Analog Scale.	Pain scores reported immediately after intravitreal injection.

Secondary Outcomes

Measure	Description	Time Frame
To elucidate the most effective topical agent for intravitreal injections.	Patients will measure pain by the use of a Visual Analog Scale.	Pain scores reported 15 minutes after intravitreal injection.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age greater than 50
Scheduled to receive Ranibizumab for neovascular AMD

Exclusion Criteria:

History of pars plana vitrectomy
Any major surgery within the prior 28 days, or one planned within next 6 months
History of thromboembolic event
Previous known allergic response to topical anesthetic(s) (lidocaine, tetracaine, cocaine)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thomas G Sheidow, MD, FRCSC	Ivey Eye Institute, St. Joseph's Health Care	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ivey Eye Institute		London	Ontario	N6A 4V2	Canada

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013748	Tetracaine
D003042	Cocaine
D008012	Lidocaine

Ancestor Terms

ID	Term
D062366	para-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic

Browse Leaves

Not provided

Browse Branches

Not provided