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

Miami VA Healthcare System

Status: Completed

Conditions: Pain

Treatments: Drug: 4% lidocaine; Drug: 3.5% ophthalmic lidocaine gel

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01087489

00825

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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53 participants in 2 patient groups

4% lidocaine

Experimental group

Description:

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

Treatment:

Drug: 4% lidocaine

3.5% ophthalmic lidocaine gel

Experimental group

Description:

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.

Treatment:

Drug: 3.5% ophthalmic lidocaine gel