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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00769392
Recruitment Status : Completed
First Posted : October 9, 2008
Results First Posted : March 21, 2019
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic

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

Condition or disease Intervention/treatment Phase
Macular Degeneration Drug: Proparacaine Ophthalmic Drug: Tetracaine Ophthalmic Drug: Lidocaine 4% Drug: Lidocaine 2% Injectable Solution Not Applicable

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 utilize 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. The order of the anesthetic treatment the subject will receive prior to each planned intravitreal injection during the study period will be different for each subject. This will decrease the effect of extraneous variables from influencing subjective pain scores.

Following each procedure, patients will fill out an analog pain scale questionnaire, grading the discomfort of receiving 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 coincides with four injections (1 injection per month) or approximately 4 months and will be followed for up to 6 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Sequential Assignment
Intervention Model Description: Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparcacaine used prior to Injection 1; Tetracaine used prior to Injection 2; Lidocaine sponge used prior to Injection 3; Lidocaine suconjunctival injection used prior to Injection 4).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
Study Start Date : September 2008
Actual Primary Completion Date : August 12, 2009
Actual Study Completion Date : August 12, 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
All Participants
All Participants will be randomized to receive a unique sequence of one of the 4 anesthetic agents per month, prior to a standard of care monthly intravitreal injection (1 injection per month for a total of 4 months). At the end of study participation, each patient will have received each of the 4 anesthetic agents once prior to one of the 4 intravitreal injections (ex. Randomization to sequence: Proparacaine Ophthalmic drops used prior to Injection 1; Tetracaine Ophthalmic drops used prior to Injection 2; Lidocaine 4% sponge used prior to Injection 3; Lidocaine 2% injectable solution (subconjunctival) used prior to Injection 4).
Drug: Proparacaine Ophthalmic
Drops of Proparacaine on the eye, administered as described in the package insert

Drug: Tetracaine Ophthalmic
Drops of Tetracaine on the eye, administered as described in the package insert

Drug: Lidocaine 4%
A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva

Drug: Lidocaine 2% Injectable Solution
A subconjunctival injection of Lidocaine 2%




Primary Outcome Measures :
  1. Discomfort Associated With the Intravitreal Injection [ Time Frame: 16 weeks ]
    Discomfort Associated With the Intravitreal Injection using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10)


Secondary Outcome Measures :
  1. Discomfort From Anesthesia Used Prior to Intravitreal Injections [ Time Frame: 16 weeks ]
    Discomfort from Anesthesia used prior to Intravitreal Injections using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10).



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00769392


Locations
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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
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Principal Investigator: Gregory R. Blaha, M.D., Ph.D. Lahey Clinic, Inc.
Publications:
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Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT00769392    
Other Study ID Numbers: 2008-076
First Posted: October 9, 2008    Key Record Dates
Results First Posted: March 21, 2019
Last Update Posted: March 9, 2020
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Lahey Clinic:
Macular Degeneration
Intravitreal injections
Eye anesthesia-Topical/subconjunctival
Eye-surgical procedures
Ophthalmologic anesthesia methods
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lidocaine
Tetracaine
Proxymetacaine
Anesthetics, Local
Anesthetics
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