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

This study has been completed.
Information provided by (Responsible Party):
Joseph Selem, Hermann Eye Center Identifier:
First received: January 21, 2009
Last updated: July 11, 2014
Last verified: July 2014
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 Intervention
Cataracts Drug: tetracaine 0.5% Drug: Lidocaine 2% Jelly

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:

Further study details as provided by Joseph Selem, Hermann Eye Center:

Primary Outcome Measures:
  • 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.

  • 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) ]

Enrollment: 40
Study Start Date: November 2008
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%

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%.

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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00827073

United States, Texas
Memorial Hermann Plaza Surgery Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Hermann Eye Center
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
  More Information


Responsible Party: Joseph Selem, Principle Investigator, Hermann Eye Center Identifier: NCT00827073     History of Changes
Other Study ID Numbers: HSC-MS-08-0454
Study First Received: January 21, 2009
Results First Received: March 11, 2014
Last Updated: July 11, 2014

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Anesthetics, Local
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 processed this record on August 22, 2017