CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 57 enrolled
Drug / intervention
Proparacaine Hydrochloride 0.5% Drop +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01640171
NCT01640171N/ACompleted

Topical Lidocaine Gel With and Without Subconjunctival Lidocaine Injection for Intravitreal Injection: a Within-patient Study

Retina Vitreous Associates of Florida·interventional·Posted Jul 13, 2012·Updated Apr 21, 2014

In Brief

A clinical study evaluating Xylocaine 2% Injectable Anesthetic, Proparacaine Hydrochloride 0.5% Drop, and 3 other interventions for Age-related Macular Degeneration and 2 related conditions. Completed, enrolled 57 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 13, 2012
Enrollment StartJul 1, 2012
Primary CompletionSep 1, 2013
Study CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 14.0 years ago

Interventions

Xylocaine 2% Injectable Anestheticprocedure

xylocaine 2% injection 0.1 cc

Proparacaine Hydrochloride 0.5% Dropdrug

Topical drop given first to the treated eye.

Tetravisc 0.5% Geldrug

Gel applied to eye 3 times prior to treatment

Acuvaildrug

Anti-inflammatory drop given after treatment

Intra-vitreal Anti-VEGF Drugdrug

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