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

Study Overview
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Brief Summary
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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
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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%.

Official Title
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The Effects on Betadine 5% Penetration When Using Lidocaine 2% Jelly Versus Topical Tetracaine 0.5% for Topical Phacoemulsification Cataract Surgery.

Conditions
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Cataracts

Intervention / Treatment
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* Drug: tetracaine 0.5%
* Drug: Lidocaine 2% Jelly


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tetracaine 0.5% drop<br>Tetracaine 0.5% drop of betadine will be used on the operative eye after Tetracaine has been administered | Drug: tetracaine 0.5%<br>* betadine 5%<br>|
| Active Comparator: Lidocaine 2% Jelly<br>Lidocaine 2% Jelly drop of betadine will be used on the operative eye after Lidocaine 2% Jelly has been administered | Drug: Lidocaine 2% Jelly<br>* Betadine 5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs | 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. | (1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery) | 
| 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) |