Clinical trial NCT01087489: Comparison of Patient Comfort After Two Anesthetic Protocols for Injections Into the Eye
Official title: Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: pain
discomfort
anesthetic drugs
topical drug administration
injections, intraocular
lidocaine
intraocular pressure
keratopathy
Lead sponsor: Miami VA Healthcare System
Sponsor class: FED
Collaborators: name: University of Miami
name: Bascom Palmer Eye Institute
First posted: 2010-03-16
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection
timeFrame: immediately after injection, 1- hour later, and next day
Secondary outcomes:
measure: Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg
timeFrame: immediately after injection, at 5, 10, 15 minutes
measure: Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage
timeFrame: within 10 minutes of the injection
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Veterans Affairs Medical Center
state: Florida
Study officials:
affiliation: Miami VA Healthcare Systems
name: Ninel Gregori, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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. doi: 10.3928/15428877-20090101-05.
citation: Kozak I, Cheng L, Freeman WR. Lidocaine gel anesthesia for intravitreal drug administration. Retina. 2005 Dec;25(8):994-8. doi: 10.1097/00006982-200512000-00007.
citation: 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.
citation: 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.