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Completed

NCT Number: NCT01087489

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Miami Veterans Affairs Medical Center

Miami, Florida, 33125, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4% lidocaine

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.

Other names: lidocaine

3.5% ophthalmic lidocaine gel

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.

Other names: Akten

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Miami VA Healthcare System

Fed

Collaborators

  • Bascom Palmer Eye Institute
  • University of Miami

Registry information

Official study title

Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 16, 2010
Registry last updated
Nov 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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