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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Lahey Clinic.
Recruitment status was  Active, not recruiting
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

October 8, 2008
May 9, 2012
September 2008
October 2011   (final data collection date for primary outcome measure)
Discomfort from anesthesia for intravitreal injection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00769392 on ClinicalTrials.gov Archive Site
To examine the side effects and discomfort associated with the intravitreal injection [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection
Pilot Study: A Randomized Trial Of Anesthetic Agents For Intravitreal Injection

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Macular Degeneration
  • Drug: Proparacaine
    Drops of Proparacaine on the eye, administered as described in the package insert
  • Drug: Tetracaine
    Drops of Tetracaine on the eye, administered as described in the package insert
  • Drug: Lidocaine
    A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva
  • Drug: Lidocaine
    A subconjunctival injection of Lidocaine 2%
  • Active Comparator: 1
    Proparacaine Drops
    Intervention: Drug: Proparacaine
  • Active Comparator: 2
    Tetracaine Drops
    Intervention: Drug: Tetracaine
  • Active Comparator: 3
    Lidocaine 4% soaked cotton sponge
    Intervention: Drug: Lidocaine
  • Active Comparator: 4
    Lidocaine 2% subconjunctival injection
    Intervention: Drug: Lidocaine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
October 2012
October 2011   (final data collection date for primary outcome measure)

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)
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00769392
2008-076
No
Lahey Clinic
Lahey Clinic
Not Provided
Principal Investigator: Gregory R. Blaha, M.D., Ph.D. Lahey Clinic, Inc.
Lahey Clinic
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP