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Completed

NCT Number: NCT00827073

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

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.

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Hermann Plaza Surgery Center

Houston, Texas, 77030, United States

About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tetracaine 0.5%

Drug

betadine 5%

Lidocaine 2% Jelly

Drug

Betadine 5%

Primary outcomes

  1. 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.

  2. 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)

Sponsors and collaborators

Lead sponsor

Hermann Eye Center

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jan 22, 2009
Registry last updated
Jul 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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