Anesthesia Preference for Intravitreal Injection: Topical or Subconjunctival

NCT01640171 | Completed Results

• 1 other identifier: rvaf-2012
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Keywords

anesthesia; pain; intravitreal; anti-vegf

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Preferred Subconjunctival Anesthetic at the Third Follow-up Visit

  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.

  up to 6 months

Secondary Outcomes (2)

• Number of Participatns With Level 10 Pain on Wong-Baker Pain Scale In Subconjunctival Eye At Time of Intravitreal Injection

  24 hours

• Likert Like Pain Scale Number of Participants Who Said the Topical Eye Hurt Much More Than the Subconjunctival Eye at Time of Intravitreal Injection

  24 hours

Study Arms (1)

Top Anesthesia 1 Eye SC Lidocaine 1 Eye

OTHER

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

Interventions

Xylocaine 2% Injectable Anesthetic PROCEDURE

xylocaine 2% injection 0.1 cc

Also known as: Lidocaine, Subconjunctival, Anesthesia, Anesthetic

Top Anesthesia 1 Eye SC Lidocaine 1 Eye

Proparacaine Hydrochloride 0.5% Drop DRUG

Topical drop given first to the treated eye.

Also known as: Lidocaine, Topical, Anesthesia, Anesthetic

Top Anesthesia 1 Eye SC Lidocaine 1 Eye

Tetravisc 0.5% Gel DRUG

Gel applied to eye 3 times prior to treatment

Also known as: topical, Anesthesia, Anesthetic

Top Anesthesia 1 Eye SC Lidocaine 1 Eye

Acuvail DRUG

Anti-inflammatory drop given after treatment

Also known as: anti-inflammatory, ketorolac, topical

Top Anesthesia 1 Eye SC Lidocaine 1 Eye

Intra-vitreal Anti-VEGF Drug DRUG

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

Also known as: Lucentis, Avastin, Eylea

Top Anesthesia 1 Eye SC Lidocaine 1 Eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Pre-existing eye pain
• Uveitis

Sponsors & Collaborators

• Retina Vitreous Associates of Florida: lead

Study Sites (1)

Retina Vitreous Associates of Florida

Clearwater, Florida, 33756, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Retinal Vein Occlusion; Pain

Interventions

Lidocaine; Anesthesia; Anesthetics; proxymetacaine; Tetracaine; Gels; Ketorolac; Anti-Inflammatory Agents; Ranibizumab; Bevacizumab; aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia and Analgesia; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Most patients were treated with subconjunctival anesthetic prior to the study.

Results Point of Contact

• Title: Steven Cohen
• Organization: Retina Vitreous Associates of Florida

scohen@health.usf.edu

7274459110

Study Officials

• Steven M Cohen, MD

  Retina Vitreous Associates of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Ophthalmology

Study Record Dates

• First Submitted: July 11, 2012
• First Posted: July 13, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: April 21, 2014
• Results First Posted: April 21, 2014

Record last verified: 2014-04

Locations

US (1)