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Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
This study is currently recruiting participants.
Verified by Lahey Clinic, April 2009
First Received: October 8, 2008   Last Updated: April 24, 2009   History of Changes
Sponsored by: Lahey Clinic
Information provided by: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00769392
  Purpose

This study is designed to compare four currently used types of anesthesia used for intravitreal injection in order to evaluate the most effective method of anesthesia in reducing pain and discomfort associated with intravitreal injections.


Condition Intervention
Macular Degeneration
Drug: Proparacaine
Drug: Tetracaine
Drug: Lidocaine

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Anesthesia Macular Degeneration
Drug Information available for: Viractin Tetracaine Lidocaine Proparacaine Proparacaine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Efficacy Study
Official Title: Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • Discomfort from anesthesia for intravitreal injection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the side effects and discomfort associated with the intravitreal injection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: September 2008
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Proparacaine Drops
Drug: Proparacaine
Drops of Proparacaine on the eye, administered as described in the package insert
2: Active Comparator
Tetracaine Drops
Drug: Tetracaine
Drops of Tetracaine on the eye, administered as described in the package insert
3: Active Comparator
Lidocaine 4% soaked cotton sponge
Drug: Lidocaine
A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva
4: Active Comparator
Lidocaine 2% subconjunctival injection
Drug: Lidocaine
A subconjunctival injection of Lidocaine 2%

Detailed Description:

Over the last several years intravitreal injection of pharmacologic agents has become a common procedure in ophthalmology. Injected agents include steroid, antibiotics, and most recently anti-VEGF agents. There are many methods of preparing a patient for intravitreal injection. While there are guidelines for infection prophylaxis, there is currently no standard of care or consensus on which method of anesthesia is most effective in reducing pain and discomfort associated with intravitreal injections.

Patients who have received prior injections and are scheduled to continue regular injections will be randomized to one of four types of anesthetic treatment for each of 4 treatment periods, so that each subject receives all four types of anesthesia over the course of the study, although the order will be different for each subject.

Following each procedure, patients will fill out a questionnaire, grading the discomfort of both the anesthesia and the injection(on separate 0-10 scales).

The anesthetic methods used will include: 1.) Drops of Proparacaine on the eye, 2.) Drops of Tetracaine on the eye, 3.) A cotton sponge (pledget) soaked with Lidocaine 4% placed over the conjunctiva and 4.)A subconjunctival injection with 2% Lidocaine.

The subjects' number and type of visits, tests and treatments will be standard of care and will not be different due to the study. The total time for the treatment part of the study is the four injections or approximately 4 months and will be followed for up to 6 months.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female > 40 years of age
  • Diagnosis of age-related macular degeneration
  • History of at least 1 intravitreal injection in the past in either eye
  • Written informed consent has been obtained

Exclusion Criteria:

  • Known allergy or sensitivity to the study medications(s), it's components, or other agents required for the study procedures(e.g. Povidone iodine)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00769392

Contacts
Contact: Gregory R. Blaha, M.D., Ph.D. 978-538-4400 Gregory.R.Blaha@Lahey.org
Contact: Avon P. Stewart 978-538-4412 Avon.P.Stewart@Lahey.org

Locations
United States, Massachusetts
Lahey Clinic, Inc. Recruiting
Burlington, Massachusetts, United States, 01805
Contact: Gregory R. Blaha, M.D., Ph.D.     781-744-8555     Gregory.R.Blaha@Lahey.org    
Sub-Investigator: Elisha P. Tilton, M.D.            
Sub-Investigator: Jeffrey L. Marx, M.D.            
Sub-Investigator: Fina C. Barouch, M.D.            
Lahey Clinic Northshore Recruiting
Peabody, Massachusetts, United States, 01960
Contact: Avon P. Stewart     978-538-4412     Avon.P.Stewart@Lahey.org    
Contact: Molly J. Concannon     978-538-4432     Molly.J.Concannon@Lahey.org    
Sub-Investigator: Jeffrey L. Marx, M.D.            
Sub-Investigator: Fina C. Barouch, M.D.            
Sub-Investigator: Elisha P. Tilton, M.D.            
Lahey Clinic Arlington Recruiting
Arlington, Massachusetts, United States, 02474
Contact: Gregory R. Blaha, M.D., Ph.D.     781-744-7143     Gregory.R.Blaha@Lahey.org    
Sub-Investigator: Fina C. Barouch, M.D.            
Sub-Investigator: Elisha P. Tilton, M.D.            
Sub-Investigator: Jeffrey L. Marx, M.D.            
Sponsors and Collaborators
Lahey Clinic
Investigators
Principal Investigator: Gregory R. Blaha, M.D., Ph.D. Lahey Clinic, Inc.
  More Information

Publications:
Responsible Party: Lahey Clinic, Inc. ( Gregory R. Blaha, M.D., Ph.D. )
Study ID Numbers: 2008-076
Study First Received: October 8, 2008
Last Updated: April 24, 2009
ClinicalTrials.gov Identifier: NCT00769392     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
Macular Degeneration
Intravitreal injections
Eye anesthesia-Topical/subconjunctival
Eye-surgical procedures
Ophthalmologic anesthesia methods

Study placed in the following topic categories:
Eye Diseases
Lidocaine
Macular Degeneration
Retinal Degeneration
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Proxymetacaine
Anesthetics, Local
Tetracaine
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Retinal Diseases

Additional relevant MeSH terms:
Eye Diseases
Physiological Effects of Drugs
Lidocaine
Macular Degeneration
Retinal Degeneration
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents
Proxymetacaine
Anesthetics, Local
Pharmacologic Actions
Tetracaine
Sensory System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009