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

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ClinicalTrials.gov Identifier: NCT01087489
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : November 20, 2012
Last Update Posted : November 20, 2012
Sponsor:
Collaborators:
University of Miami
Bascom Palmer Eye Institute
Information provided by (Responsible Party):
Ninel Gregori, 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.

Condition or disease Intervention/treatment Phase
Pain Drug: 4% lidocaine Drug: 3.5% ophthalmic lidocaine gel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Clinical Comparison of Two Anesthetic Preparations for Intravitreal Injection
Study Start Date : April 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: 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.
Other Name: lidocaine

Experimental: 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.
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.
Other Name: Akten




Primary Outcome Measures :
  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 Outcome Measures :
  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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01087489


Locations
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United States, Florida
Miami Veterans Affairs Medical Center
Miami, Florida, United States, 33125
Sponsors and Collaborators
Miami VA Healthcare System
University of Miami
Bascom Palmer Eye Institute
Investigators
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Principal Investigator: Ninel Gregori, MD Miami VA Healthcare Systems
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ninel Gregori, Assistant Professor of Clinical Ophthalmology, Miami VA Healthcare System
ClinicalTrials.gov Identifier: NCT01087489    
Other Study ID Numbers: 00825
First Posted: March 16, 2010    Key Record Dates
Results First Posted: November 20, 2012
Last Update Posted: November 20, 2012
Last Verified: November 2012
Keywords provided by Ninel Gregori, Miami VA Healthcare System:
pain
discomfort
anesthetic drugs
topical drug administration
injections, intraocular
lidocaine
intraocular pressure
keratopathy
Additional relevant MeSH terms:
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Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action