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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
Sponsor:
Information provided by (Responsible Party):
Steven Cohen, MD, Retina Vitreous Associates of Florida

Brief 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).


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Top Anesthesia 1 Eye SC Lidocaine 1 Eye

One eye:

Proparacaine Hydrochloride 0.5% Drop Tetravisc 0.5% Gel Acuvail Intra-vitreal Anti-VEGF Drug

Fellow Eye:

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
Other Names:
  • Lidocaine
  • Subconjunctival
  • Anesthesia
  • Anesthetic

Drug: Proparacaine Hydrochloride 0.5% Drop
Topical drop given first to the treated eye.
Other Names:
  • Lidocaine
  • Topical
  • Anesthesia
  • Anesthetic

Drug: Tetravisc 0.5% Gel
Gel applied to eye 3 times prior to treatment
Other Names:
  • topical
  • Anesthesia
  • Anesthetic

Drug: Acuvail
Anti-inflammatory drop given after treatment
Other Names:
  • anti-inflammatory
  • ketorolac
  • topical

Drug: Intra-vitreal Anti-VEGF Drug
Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion
Other Names:
  • Lucentis
  • Avastin
  • Eylea




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pre-existing eye pain
  • Uveitis

Information from the National Library of Medicine

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


Locations
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United States, Florida
Retina Vitreous Associates of Florida
Clearwater, Florida, United States, 33756
Sponsors and Collaborators
Retina Vitreous Associates of Florida
Investigators
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Principal Investigator: Steven M Cohen, MD Retina Vitreous Associates of Florida

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Responsible Party: Steven Cohen, MD, Clinical Professor of Ophthalmology, Retina Vitreous Associates of Florida
ClinicalTrials.gov Identifier: NCT01640171     History of Changes
Other Study ID Numbers: rvaf-2012
First Posted: July 13, 2012    Key Record Dates
Results First Posted: April 21, 2014
Last Update Posted: April 21, 2014
Last Verified: April 2014
Keywords provided by Steven Cohen, MD, Retina Vitreous Associates of Florida:
anesthesia
pain
intravitreal
anti-vegf
Additional relevant MeSH terms:
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Macular Degeneration
Macular Edema
Retinal Vein Occlusion
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Ketorolac
Ketorolac Tromethamine
Bevacizumab
Lidocaine
Anesthetics
Proxymetacaine
Propoxycaine
Tetracaine
Anti-Inflammatory Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action