Clinical trial NCT00827073: Comparison of Tetracaine 0.5% and Lidocaine 2% Jelly for Topical Phacoemulsification Cataract Surgery
Official title: The Effects on Betadine 5% Penetration When Using Lidocaine 2% Jelly Versus Topical Tetracaine 0.5% for Topical Phacoemulsification Cataract Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataracts
Lead sponsor: Hermann Eye Center
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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%.

Eligibility 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

Primary outcomes:
measure: Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs
timeFrame: (1) Pre-antibiotics swab, and (2) Post-study medication (pre surgery)
measure: Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs
timeFrame: (1) Pre-antibiotics swab and (2) Post-study medication (pre surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Plaza Surgery Center
state: Texas
Study officials:
affiliation: Robert Cizik Eye Clinic and Department of Ophthalmology and Visual Science at The University of Texas Medical School at Houston
name: Nan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
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