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N/A N=57 Single-blind Treatment

Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival

Age-related Macular Degeneration · Central Retinal Vein Occlusion · Diabetic Macular Edema

Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit — 50 participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Xylocaine 2% Injectable Anesthetic (Procedure); Proparacaine Hydrochloride 0.5% Drop (Drug); Tetravisc 0.5% Gel (Drug); Acuvail (Drug); Intra-vitreal Anti-VEGF Drug (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Retina Vitreous Associates of Florida
Primary completion
Sep 2013

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit
50
SECONDARY
Number of Participatns With Level 10 Pain on Wong-Baker Pain Scale In Subconjunctival Eye At Time of Intravitreal Injection
SECONDARY
Likert Like Pain Scale Number of Participants Who Said the Topical Eye Hurt Much More Than the Subconjunctival Eye at Time of Intravitreal Injection
19

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).

Eligibility Criteria

Inclusion Criteria

  • Patient receiving bilateral intravitreal injections
  • Ability to give informed consent

Exclusion Criteria

  • Pre-existing eye pain
  • Uveitis
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01640171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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