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

NCT00769392 | Completed Results

• 1 other identifier: 2008-076
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

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.

Conditions

Macular Degeneration

Keywords

Macular Degeneration; Intravitreal injections; Eye anesthesia-Topical/subconjunctival; Eye-surgical procedures; Ophthalmologic anesthesia methods

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Discomfort From Anesthesia Used Prior to Intravitreal Injections

  16 weeks

Study Arms (1)

All Participants

OTHER

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; Drug: Tetracaine Ophthalmic; Drug: Lidocaine 4%; Drug: Lidocaine 2% Injectable Solution

Interventions

Proparacaine Ophthalmic DRUG

Drops of Proparacaine on the eye, administered as described in the package insert

All Participants

Tetracaine Ophthalmic DRUG

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

All Participants

Lidocaine 4% DRUG

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

All Participants

Lidocaine 2% Injectable Solution DRUG

A subconjunctival injection of Lidocaine 2%

All Participants

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known allergy or sensitivity to the study medications(s), it's components, or other agents required for the study procedures(e.g. Povidone iodine)

Sponsors & Collaborators

• Lahey Clinic: lead

Study Sites (3)

Lahey Clinic Arlington

Arlington, Massachusetts, 02474, United States

Location

Lahey Clinic, Inc.

Burlington, Massachusetts, 01805, United States

Location

Lahey Clinic Northshore

Peabody, Massachusetts, 01960, United States

Location

Related 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. doi: 10.1177/112067210601600509.

  PMID: 17061223 BACKGROUND

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

  PMID: 18306942 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Limitations of any study examining pain are the subjective nature of pain, the difficulty in measurement, and patient variability. This was address by using a randomized block design.

Results Point of Contact

• Title: Gregory Blaha, MD
• Organization: Lahey Clinic

christine.gould@lahey.org

781-744-2580

Study Officials

• Gregory R. Blaha, M.D., Ph.D.

  Lahey Clinic, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: September 1, 2008
• Primary Completion: August 12, 2009
• Study Completion: August 12, 2009
• Last Updated: March 9, 2020
• Results First Posted: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)