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Comparison of Tetracaine 0.5% and Lidocaine 2% Jelly for Topical Phacoemulsification Cataract Surgery

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ClinicalTrials.gov Identifier: NCT00827073
Recruitment Status : Completed
First Posted : January 22, 2009
Results First Posted : June 23, 2014
Last Update Posted : July 22, 2014
Sponsor:
Information provided by (Responsible Party):
Joseph Selem, Hermann Eye Center

Brief Summary:
The purpose of this study is to determine if there is a difference on the penetration of betadine 5% when using lidocaine 2% jelly versus topical tetracaine 0.5% in topical cataract surgery. This will be assessed comparing bacterial colony count and species by taking swabs from the eye surface before and after the topical anesthesia has been administered.

Condition or disease Intervention/treatment
Cataracts Drug: tetracaine 0.5% Drug: Lidocaine 2% Jelly

Detailed Description:
The purpose of this research study is to show that using Lidocaine2% jelly before surgery as an anesthetic (keep you from feeling touch or pain) for cataract surgery does not block the antiseptic (cleans and kills germs) effect of Betadine5%.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effects on Betadine 5% Penetration When Using Lidocaine 2% Jelly Versus Topical Tetracaine 0.5% for Topical Phacoemulsification Cataract Surgery.
Study Start Date : November 2008
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Tetracaine 0.5% drop
Tetracaine 0.5% drop of betadine will be used on the operative eye after Tetracaine has been administered
Drug: tetracaine 0.5%
betadine 5%
Active Comparator: Lidocaine 2% Jelly
Lidocaine 2% Jelly drop of betadine will be used on the operative eye after Lidocaine 2% Jelly has been administered
Drug: Lidocaine 2% Jelly
Betadine 5%



Primary Outcome Measures :
  1. Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs [ Time Frame: (1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery) ]
    Within 3 hours from time of culture acquisition, the samples will be vortexed for 30 seconds and 100µl aliquots will be plated onto 5% sheep blood and chocolate agar plates. These plates will be incubated with 5% carbon dioxide at 35˚ C for 72 hours. After 72 hours all plates will be read for colony count and identification of all isolates will be performed using routine microbiological methods. The natural log of bacterial bacterial colony count will be used for the outcome measure.

  2. Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs [ Time Frame: (1) Pre-antibiotics swab and (2) Post-study medication (pre surgery) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • greater or equal to 18 years old
  • uni- or bi-lateral visually significant cataracts

Exclusion Criteria:

  • hypersensitivity to betadine5%, topical tetracaine0.5%, or lidocaine2% jelly
  • pregnancy

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): NCT00827073


Locations
United States, Texas
Memorial Hermann Plaza Surgery Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hermann Eye Center
Investigators
Principal Investigator: Nan Wang, MD Robert Cizik Eye Clinic and Department of Ophthalmology and Visual Science at The University of Texas Medical School at Houston

Publications:

Responsible Party: Joseph Selem, Principle Investigator, Hermann Eye Center
ClinicalTrials.gov Identifier: NCT00827073     History of Changes
Other Study ID Numbers: HSC-MS-08-0454
First Posted: January 22, 2009    Key Record Dates
Results First Posted: June 23, 2014
Last Update Posted: July 22, 2014
Last Verified: July 2014

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Lidocaine
Tetracaine
Povidone-Iodine
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
Anti-Infective Agents, Local
Anti-Infective Agents