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

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00769392
• Other study ID #: 2008-076
• Status: Completed
• Phase: N/A
• Start date: September 2008
• Est. completion date: August 12, 2009

Study information

• Verified date: March 2019
• Source: Lahey Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 12, 2009
• Est. primary completion date: August 12, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Macular Degeneration

Intervention

Drug:
• Proparacaine Ophthalmic
Drops of Proparacaine on the eye, administered as described in the package insert
• Tetracaine Ophthalmic
Drops of Tetracaine on the eye, administered as described in the package insert
• Lidocaine 4%
A cotton sponge(pledget)soaked with Lidocaine 4% placed over the conjunctiva
• Lidocaine 2% Injectable Solution
A subconjunctival injection of Lidocaine 2%

Locations

Country	Name	City	State
United States	Lahey Clinic Arlington	Arlington	Massachusetts
United States	Lahey Clinic, Inc.	Burlington	Massachusetts
United States	Lahey Clinic Northshore	Peabody	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Lahey Clinic

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kaderli B, Avci R. Comparison of topical and subconjunctival anesthesia in intravitreal injection administrations. Eur J Ophthalmol. 2006 Sep-Oct;16(5):718-21. — View Citation

Landry DA. Topical anesthetic pledgett system (TAPS) for intravitreal injection preparation. Insight. 2007 Oct-Dec;32(4):20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort Associated With the Intravitreal Injection	Discomfort Associated With the Intravitreal Injection using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10)	16 weeks
Secondary	Discomfort From Anesthesia Used Prior to Intravitreal Injections	Discomfort from Anesthesia used prior to Intravitreal Injections using a Subjective Analog Pain Scale (0-10); no pain (0) and severe pain (10).	16 weeks