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

NCT ID: NCT01087489

Last Updated: 2012-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-06-30

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.

Conditions

Pain

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

4% lidocaine

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

3.5% ophthalmic lidocaine gel

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

lidocaine; Akten

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

Bascom Palmer Eye Institute

OTHER

Sponsor Role: collaborator

Miami VA Healthcare System

FED

Sponsor Role: lead

Responsible Party

Ninel Gregori

Assistant Professor of Clinical Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ninel Gregori, MD

Role: PRINCIPAL_INVESTIGATOR

Miami VA Healthcare Systems

Locations

Miami Veterans Affairs Medical Center

Miami, Florida, United States

Countries

United States

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: DERIVED

PMID: 23632408 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22554019 (View on PubMed)

Other Identifiers

00825

Identifier Type: -

Identifier Source: org_study_id