Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye - Full Text View

Purpose

Patient comfort during and after eye injections will be compared after two numbing (anesthetic) protocols, an eye preparation utilizing three cotton swabs soaked in 4% lidocaine drops versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel.

Condition	Intervention
Pain	Drug: 4% lidocaine Drug: 3.5% ophthalmic lidocaine gel

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection

Resource links provided by NLM:

Drug Information available for: Lidocaine hydrochloride Lidocaine Proxymetacaine

U.S. FDA Resources

Further study details as provided by Miami VA Healthcare System:

Primary Outcome Measures:

Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection [ Time Frame: immediately after injection, 1- hour later, and next day ] [ Designated as safety issue: No ]
Discomfort according to the Eye Sensation Scale: 1-none, 2- mild, 3- moderate, 4- severe, 5- extremely severe

Patient satisfaction scale: 1=very unsatisfied, 2=unsatisfied, 3=neutral, 4=satisfied, 5= extremely satisfied

Secondary Outcome Measures:

Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg [ Time Frame: immediately after injection, at 5, 10, 15 minutes ] [ Designated as safety issue: Yes ]
intraocular pressure (IOP) was measured immediately after the injection, and at 5, 10, and 15 minutes after the injection (until it was 30 mmHg or below). Prior to injection IOP and post-injection IOP were compared to find the IOP change after injection.
Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage [ Time Frame: within 10 minutes of the injection ] [ Designated as safety issue: Yes ]
Presence of corneal staining after the injection:
- Quadrants of fluorescein staining: 0 1 2 3 4
- Density of staining: 0- None 1- Mild 2- Moderate 3- Severe 4- corneal abrasion
Size of subconjunctival hemorrhage:

in clock hours

Enrollment:	53
Study Start Date:	April 2010
Study Completion Date:	June 2011
Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 4% lidocaine Eyes were anesthetized with 0.5% proparacaine and then with three cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of the injection inferotemporally to the limbus. Each participant was assigned to have this prep during one of the consecutive study visits if unilateral or in one eye if patient requires bilateral injections given the same day	Drug: 4% lidocaine The eye will be topically anesthetized with 0.5% proparacaine drops and 4% lidocaine drops and a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface followed in three rounds by additional 5% povidone iodine and a sterile cotton swab soaked in sterile 4% lidocaine applied with gentle pressure to the area designated for injection in the infero-temporal quadrant. Other Name: lidocaine
Experimental: 3.5% ophthalmic lidocaine gel Eye was anesthetized with 0.5% proparacaine and then with 3.5% ophthalmic lidocaine gel applied to the surface of the eye. Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day.	Drug: 3.5% ophthalmic lidocaine gel The eye will be topically anesthetized with 0.5% proparacaine drops and 5% povidone iodine will be placed over the eye. Two drops of preservative-free 3.5% lidocaine hydrochloride ophthalmic gel will be placed into inferior conjunctival sac. The patient will be asked to close the eye for 7 minutes. Next, a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface and allowed to remain in contact with the eye for at least 2 minutes. The eye will then be rinsed with antibiotic drops. Other Name: Akten

Arms

Assigned Interventions

Experimental: 4% lidocaine

Eyes were anesthetized with 0.5% proparacaine and then with three cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of the injection inferotemporally to the limbus. Each participant was assigned to have this prep during one of the consecutive study visits if unilateral or in one eye if patient requires bilateral injections given the same day

Drug: 4% lidocaine

The eye will be topically anesthetized with 0.5% proparacaine drops and 4% lidocaine drops and a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface followed in three rounds by additional 5% povidone iodine and a sterile cotton swab soaked in sterile 4% lidocaine applied with gentle pressure to the area designated for injection in the infero-temporal quadrant.

Other Name: lidocaine

Experimental: 3.5% ophthalmic lidocaine gel

Eye was anesthetized with 0.5% proparacaine and then with 3.5% ophthalmic lidocaine gel applied to the surface of the eye. Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day.

Drug: 3.5% ophthalmic lidocaine gel

The eye will be topically anesthetized with 0.5% proparacaine drops and 5% povidone iodine will be placed over the eye. Two drops of preservative-free 3.5% lidocaine hydrochloride ophthalmic gel will be placed into inferior conjunctival sac. The patient will be asked to close the eye for 7 minutes. Next, a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface and allowed to remain in contact with the eye for at least 2 minutes. The eye will then be rinsed with antibiotic drops.

Other Name: Akten

Detailed Description:

The primary goal of this investigation is to determine the relative comfort of an intravitreal injection (same day and the next day) after a preparation utilizing three cotton swabs soaked in 4% lidocaine versus a preparation using 3.5% lidocaine hydrochloride ophthalmic gel. Based on the available data, the researchers contend that a preparation based on viscous 3.5% ophthalmic lidocaine gel, which coats the surface and remains in contact with the eye longer, may provide greater anesthesia and result in greater patient comfort than the topical 4% lidocaine, which is part of the standard preparation routinely utilized in the ophthalmology department currently. Secondary outcome measure is the intraocular pressure rise after the injection, and the authors will generate prospective data to study whether softening the eye with cotton swabs prior to the injection lowers post-injection pressure spike.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Has required repeat Ranibizumab injections and has had at least 3 injections prior to recruitment
Informed consent
Age ≥ 18 years
Clinical need for a therapeutic ranibizumab intravitreal injection regardless of the medical indication
Able to understand and read English

Exclusion Criteria:

Pregnancy (positive pregnancy test)
Mental disability
Prisoners
Patients with fluctuating or impaired decision-making capacity
Inability to comply with study or follow-up procedures
Previous reaction to the same drug class

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01087489

Locations

United States, Florida
Miami Veterans Affairs Medical Center
Miami, Florida, United States, 33125

Sponsors and Collaborators

Miami VA Healthcare System

University of Miami

Bascom Palmer Eye Institute

Investigators

Principal Investigator:

Ninel Gregori, MD

Miami VA Healthcare Systems

More Information

Publications:

Friedman SM, Margo CE. Topical gel vs subconjunctival lidocaine for intravitreous injection: a randomized clinical trial. Am J Ophthalmol. 2006 Nov;142(5):887-8.

Caudle LE, Williams KA, Pesudovs K. The Eye Sensation Scale: an ophthalmic pain severity measure. Optom Vis Sci. 2007 Aug;84(8):752-62.

Chalam KV, Murthy RK, Agarwal S, Gupta SK, Grover S. Comparative efficacy of topical tetraVisc versus lidocaine gel in cataract surgery. BMC Ophthalmol. 2009 Aug 17;9:7.

Busbee BG, Alam A, Reichel E. Lidocaine hydrochloride gel for ocular anesthesia: results of a prospective, randomized study. Ophthalmic Surg Lasers Imaging. 2008 Sep-Oct;39(5):386-90.

Page MA, Fraunfelder FW. Safety, efficacy, and patient acceptability of lidocaine hydrochloride ophthalmic gel as a topical ocular anesthetic for use in ophthalmic procedures. Clin Ophthalmol. 2009;3:601-9. Epub 2009 Nov 2.

Soliman MM, Macky TA, Samir MK. Comparative clinical trial of topical anesthetic agents in cataract surgery: lidocaine 2% gel, bupivacaine 0.5% drops, and benoxinate 0.4% drops. J Cataract Refract Surg. 2004 Aug;30(8):1716-20.

Bardocci A, Lofoco G, Perdicaro S, Ciucci F, Manna L. Lidocaine 2% gel versus lidocaine 4% unpreserved drops for topical anesthesia in cataract surgery: a randomized controlled trial. Ophthalmology. 2003 Jan;110(1):144-9.

Cintra LP, Lucena LR, Da Silva JA, Costa RA, Scott IU, Jorge R. Comparative study of analgesic effectiveness using three different anesthetic techniques for intravitreal injection of bevacizumab. Ophthalmic Surg Lasers Imaging. 2009 Jan-Feb;40(1):13-8.

Kozak I, Cheng L, Freeman WR. Lidocaine gel anesthesia for intravitreal drug administration. Retina. 2005 Dec;25(8):994-8.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Gregori NZ, Weiss MJ, Goldhardt R, Schiffman JC, Vega E, Mattis CA, Shi W, Kelley L, Hernandez V, Feuer WJ. Randomized clinical trial of two anesthetic techniques for intravitreal injections: 4% liquid lidocaine on cotton swabs versus 3.5% lidocaine gel. Expert Opin Drug Deliv. 2012 Jul;9(7):735-41. Epub 2012 May 3.

Responsible Party:	Ninel Gregori, Assistant Professor of Clinical Ophthalmology, Miami VA Healthcare System
ClinicalTrials.gov Identifier:	NCT01087489 History of Changes
Other Study ID Numbers:	00825
Study First Received:	March 15, 2010
Results First Received:	April 28, 2012
Last Updated:	November 19, 2012
Health Authority:	United States: Federal Government

Keywords provided by Miami VA Healthcare System:

pain
discomfort
anesthetic drugs
topical drug administration

injections, intraocular
lidocaine
intraocular pressure
keratopathy

Additional relevant MeSH terms:

Anesthetics
Lidocaine
Proxymetacaine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents

Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013