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

Not Applicable

Completed

• Conditions: Cataracts
• Interventions: Drug: tetracaine 0.5%; Drug: Lidocaine 2% Jelly

• Registration Number: NCT00827073
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-01-21
• Study First Submitted QC: 2009-01-21
• Study First Posted: 2009-01-22
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2014-03-11
• Results First Submitted QC: 2014-05-20
• Results First Posted: 2014-06-23
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-11
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tetracaine 0.5% drop	tetracaine 0.5%	Tetracaine 0.5% drop of betadine will be used on the operative eye after Tetracaine has been administered
Lidocaine 2% Jelly	Lidocaine 2% Jelly	Lidocaine 2% Jelly drop of betadine will be used on the operative eye after Lidocaine 2% Jelly has been administered

Primary Outcome Measures

Name	Time	Method
Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs	(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	(1) Pre-antibiotics swab and (2) Post-study medication (pre surgery)

Trial Locations

Locations (1)

Memorial Hermann Plaza Surgery Center; 🇺🇸 Houston, Texas, United States