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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joseph Selem, Hermann Eye Center
ClinicalTrials.gov Identifier:
NCT00827073
First received: January 21, 2009
Last updated: July 11, 2014
Last verified: July 2014
  Purpose

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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]

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%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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
Study First Received: January 21, 2009
Results First Received: March 11, 2014
Last Updated: July 11, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Lidocaine
Tetracaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014