Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye

• ClinicalTrials.gov Identifier: NCT01087489
• Recruitment Status: Completed
• First Posted: March 16, 2010
• Results First Posted: November 20, 2012
• Last Update Posted: November 20, 2012
• Sponsor: Miami VA Healthcare System
• Collaborators: University of Miami; Bascom Palmer Eye Institute
• Information provided by (Responsible Party): Ninel Gregori, Miami VA Healthcare System

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pain	Drug: 4% lidocaine; Drug: 3.5% ophthalmic lidocaine gel	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection
• Study Start Date: April 2010
• Actual Primary Completion Date: March 2011
• Actual Study Completion Date: June 2011

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection [ Time Frame: immediately after injection, 1- hour later, and next day ]

   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 :

1. Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg [ Time Frame: immediately after injection, at 5, 10, 15 minutes ]
   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.
2. Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage [ Time Frame: within 10 minutes of the injection ]

   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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. doi: 10.1186/1471-2415-9-7.

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.

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. Ocular decompression with cotton swabs lowers intraocular pressure elevation after intravitreal injection. J Glaucoma. 2014 Oct-Nov;23(8):508-12. doi: 10.1097/IJG.0b013e318294865c.

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. doi: 10.1517/17425247.2012.685155. Epub 2012 May 3.

• Responsible Party: Ninel Gregori, Assistant Professor of Clinical Ophthalmology, Miami VA Healthcare System
• ClinicalTrials.gov Identifier: NCT01087489
• Other Study ID Numbers: 00825
• First Posted: March 16, 2010
• Results First Posted: November 20, 2012
• Last Update Posted: November 20, 2012
• Last Verified: November 2012

Keywords provided by Ninel Gregori, Miami VA Healthcare System:

pain; discomfort; anesthetic drugs; topical drug administration; injections, intraocular; lidocaine; intraocular pressure; keratopathy

Additional relevant MeSH terms:

Lidocaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; 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