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Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival

NCT01640171 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2014-04-21

Study results available
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Summary

Since 2004, intravitreal injection of Avastin, Lucentis, and Macugen for wet age-related macular degeneration, retinal vein occlusion, and diabetic macular edema are being administered in the United States at increasing rates. A 2010 study showed that in Canada and the incidence of injections grew 8 fold from 2005 to 2007 to 25.9 injections per 100,000 citizens. (Campbell 2010) In 2009, in the United States, over 1 million intravitreal injections were administered to Medicare beneficiaries. (Wykoff 2011) In the year 2011, the four doctors in my retina group administered a total of 6,494 intravitreal injections; in 2010, we administered 5021 intravitreal injections.

Even though intravitreal injections are commonly administered, the optimal method of anesthetizing the eye prior to injection has yet to be determined. Some physicians use an anesthetic drop, some a soaked cotton pledget, some use an anesthetic gel and some use subconjunctival injected anesthetic.

In 2009, the last time the Procedures and Trends Survey (PAT) (Mittra 2009) conducted by the American Society of Retina Specialists (the largest retina society in the world) asked about anesthetic methods for administering intravitreal injections, the following response was given by the 433 respondents:

* Topical anesthetic drop: 21.48%
* Topical viscous anesthetic: 23.33%
* Topical anesthetic \& soaked cotton-tip or pledget: 29.79%
* Subconjunctival injection of anesthetic: 24.02%
* Other: 1.39%

An editorial in 2011 in the journal Retina, discusses the lack of good studies assessing optimal anesthetic prior to intravitreal injections. (Prenner 2011).

Conditions

Interventions

PROCEDURE

Xylocaine 2% Injectable Anesthetic

xylocaine 2% injection 0.1 cc

DRUG

Proparacaine Hydrochloride 0.5% Drop

Topical drop given first to the treated eye.

DRUG

Tetravisc 0.5% Gel

Gel applied to eye 3 times prior to treatment

DRUG

Acuvail

Anti-inflammatory drop given after treatment

DRUG

Intra-vitreal Anti-VEGF Drug

Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion

Sponsors & Collaborators

  • Retina Vitreous Associates of Florida

    lead OTHER

Principal Investigators

  • Steven M Cohen, MD · Retina Vitreous Associates of Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01640171 on ClinicalTrials.gov