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

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: 4% lidocaine; Drug: 3.5% ophthalmic lidocaine gel

• Registration Number: NCT01087489
• Lead Sponsor: Miami VA Healthcare System

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.

Study Timeline

• Study First Submitted: 2010-03-15
• Study First Submitted QC: 2010-03-15
• Study First Posted: 2010-03-16
• Study Start: 2010-04
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Results First Submitted: 2012-04-28
• Status Verified: 2012-11
• Results First Submitted QC: 2012-11-19
• Last Update Submitted: 2012-11-19
• Results First Posted: 2012-11-20
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
4% lidocaine	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
3.5% ophthalmic lidocaine gel	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.

Primary Outcome Measures

Name	Time	Method
Discomfort Level and Patient Satisfaction With the Preparation Protocol and Intravitreal Injection	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

Name	Time	Method
Intraocular Pressure Change After Intravitreal Injection With Each Anesthetic Method, Results Reported in mmHg	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.
Presence and Severity of Keratopathy and the Size of Subconjunctival Hemorrhage	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

Trial Locations

Locations (1)

Miami Veterans Affairs Medical Center; 🇺🇸 Miami, Florida, United States