Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival
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|ClinicalTrials.gov Identifier: NCT01640171|
Recruitment Status : Completed
First Posted : July 13, 2012
Results First Posted : April 21, 2014
Last Update Posted : April 21, 2014
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).
|Condition or disease||Intervention/treatment||Phase|
|Age-related Macular Degeneration Central Retinal Vein Occlusion Diabetic Macular Edema||Procedure: Xylocaine 2% Injectable Anesthetic Drug: Proparacaine Hydrochloride 0.5% Drop Drug: Tetravisc 0.5% Gel Drug: Acuvail Drug: Intra-vitreal Anti-VEGF Drug||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Topical Lidocaine Gel With and Without Subconjunctival Lidocaine Injection for Intravitreal Injection: a Within-patient Study|
|Study Start Date :||July 2012|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||October 2013|
Top Anesthesia 1 Eye SC Lidocaine 1 Eye
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Acuvail Intra-vitreal Anti-VEGF Drug
Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Xylocaine 2% Injectable Anesthetic Acuvail Intra-vitreal Anti-VEGF Drug
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
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
- Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit [ Time Frame: up to 6 months ]Participants received anesthetic over several treatment visits. They were allowed to change there preference at each visit. The final outcome was the preference indicated at the third follow-up visit.
- Number of Participatns With Level 10 Pain on Wong-Baker Pain Scale In Subconjunctival Eye At Time of Intravitreal Injection [ Time Frame: 24 hours ]Pain was rated on a 10 point standardized pain scale, zero was the least pain and 10 was the worst pain. The patient was questioned using a script and shown a pain scale as well as told how the pain scale worked. Then the patient gave the number that characterized their pain.
- Likert Like Pain Scale Number of Participants Who Said the Topical Eye Hurt Much More Than the Subconjunctival Eye at Time of Intravitreal Injection [ Time Frame: 24 hours ]The patient was asked to compare the two eyes in the way described in the study protocol on a five point scale. If one eye hurt a lot more or a little more than the other or if the two eyes were equal (neither hurt more than the other).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01640171
|United States, Florida|
|Retina Vitreous Associates of Florida|
|Clearwater, Florida, United States, 33756|
|Principal Investigator:||Steven M Cohen, MD||Retina Vitreous Associates of Florida|