Intravitreal Injection Anesthesia - Comparison of Different Topical Agents

Sponsor

Lawson Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01224847

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

90.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration (AMD)	Drug: Tetracaine Drug: Cocaine Drug: Lidocaine	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

92 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Intravitreal Injection Anesthesia - Comparison of Different Topical Agents.

Study Start Date :

Oct 1, 2009

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Nov 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tetracaine gtt Pre-Intravitreal injection - 1 gtt Tetracaine topically	Drug: Tetracaine 1 gtt
Active Comparator: Tetraciane gtt + Lidocaine pledget 1 gtt Tetracaine pre-IVT injection + application Lidocaine pledget to injection site	Drug: Lidocaine Lidocaine soaked pledget
Active Comparator: Cocaine gtt alone 1 gtt pre-IVT injection	Drug: Cocaine 1 gtt

Arm

Intervention/Treatment

Active Comparator: Tetracaine gtt

Pre-Intravitreal injection - 1 gtt Tetracaine topically

Drug: Tetracaine

1 gtt

Active Comparator: Tetraciane gtt + Lidocaine pledget

1 gtt Tetracaine pre-IVT injection + application Lidocaine pledget to injection site

Drug: Lidocaine

Lidocaine soaked pledget

Active Comparator: Cocaine gtt alone

1 gtt pre-IVT injection

Drug: Cocaine

1 gtt

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)