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Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic
ClinicalTrials.gov Identifier:
NCT00769392
First received: October 8, 2008
Last updated: May 9, 2012
Last verified: May 2012
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection

Resource links provided by NLM:

U.S. FDA Resources

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: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Proparacaine Drops
 Drug: Proparacaine
Drops of Proparacaine on the eye, administered as described in the package insert
Active Comparator: 2
Tetracaine Drops
 Drug: Tetracaine
Drops of Tetracaine on the eye, administered as described in the package insert
Active Comparator: 3
Lidocaine 4% soaked cotton sponge
 Drug: Lidocaine
A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva
Active Comparator: 4
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

Locations
United States, Massachusetts
Lahey Clinic Arlington
Arlington, Massachusetts, United States, 02474
Lahey Clinic, Inc.
Burlington, Massachusetts, United States, 01805
Lahey Clinic Northshore
Peabody, Massachusetts, United States, 01960
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
ClinicalTrials.gov Identifier: NCT00769392     History of Changes
Other Study ID Numbers: 2008-076
Study First Received: October 8, 2008
Last Updated: May 9, 2012
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

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

ClinicalTrials.gov processed this record on May 19, 2013