This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Lahey Clinic.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Lahey Clinic Identifier:
First received: October 8, 2008
Last updated: May 9, 2012
Last verified: May 2012
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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection

Resource links provided by NLM:

Further study details as provided by Lahey Clinic:

Primary Outcome Measures:
  • Discomfort from anesthesia for intravitreal injection [ Time Frame: 24 weeks ]

Secondary Outcome Measures:
  • To examine the side effects and discomfort associated with the intravitreal injection [ Time Frame: 24 weeks ]

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.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00769392

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
Principal Investigator: Gregory R. Blaha, M.D., Ph.D. Lahey Clinic, Inc.
  More Information

Responsible Party: Lahey Clinic Identifier: NCT00769392     History of Changes
Other Study ID Numbers: 2008-076
Study First Received: October 8, 2008
Last Updated: May 9, 2012

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, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action processed this record on August 23, 2017