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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: March 18, 2013
Last verified: March 2013
History of Changes
  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: betadine
Drug: topical tetracaine
Drug: lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group 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:

MedlinePlus related topics: Cataract
U.S. FDA Resources

Further study details as provided by Hermann Eye Center:

Primary Outcome Measures:
  • Bacterial species and colony count [ Time Frame: 1 week ] [ 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
Experimental: 1 Topical Anesthetic Drug: betadine
betadine 5%
Other Name: povidone-iodine
Drug: topical tetracaine
topical anesthetic
Other Names:
  • Ak-taine
  • Ak-T-Caine
  • Alcaine
  • Ocu-Caine
  • Ophthaine
Active Comparator: 2 Anesthetic Drug: betadine
betadine 5%
Other Name: povidone-iodine
Drug: lidocaine
lidocaine 2% jelly
Other Name: Xylocaine 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%.

  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
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
Last Updated: March 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Anesthetics
Tetracaine
Lidocaine
Povidone-Iodine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Anti-Infective Agents, Local
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 19, 2013