An interventional study of tetracaine 0.5% and Lidocaine 2% Jelly in Cataracts, sponsored by Hermann Eye Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-22.
Sponsored by Hermann Eye Center · Not applicable, Interventional, and Supportive care
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.
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%.
1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.
This study's enrollment of 40 is below the median of 80 across 1,155 interventional studies indexed under Cataract.
Browse Cataract studies →Hermann Eye Center is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Tetracaine 0.5% drop of betadine will be used on the operative eye after Tetracaine has been administered
Drug: tetracaine 0.5%
Lidocaine 2% Jelly drop of betadine will be used on the operative eye after Lidocaine 2% Jelly has been administered
Drug: Lidocaine 2% Jelly
betadine 5%
Betadine 5%
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.
Time frame: (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
Time frame: (1) Pre-antibiotics swab and (2) Post-study medication (pre surgery)
| Milestone | Tetracaine 5% Drop | Lidocaine 2% Jelly |
|---|---|---|
| Started | 20 | 20 |
| Completed | 20 | 20 |
| Not completed | 0 | 0 |
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.
| Ln(bacterial colony count) | Tetracaine 0.5% Drop | Lidocaine 2% Jelly |
|---|---|---|
| Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs | -0.14 ± 0.67 | -0.52 ± 1.85 |
| bacterial spceies | Tetracaine 0.5% Drop | Lidocaine 2% Jelly |
|---|---|---|
| pre number of bacterial spices | 1 ± 0 | 1 ± 0 |
| post surgery number of bacterial speices | 1 ± 0 | 1 ± 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tetracaine 0.5% Drop | — | 0/20 (0%) | 0/20 (0%) |
| Lidocaine 2% Jelly | — | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(year) | Tetracaine 5% Drop | Lidocaine 2% Jelly | Total |
|---|---|---|---|
| Mean | 70.0 ± 7.4 | 68.4 ± 11.8 | 69.2 ± 9.8 |
| Age, Categorical(Participants) | Tetracaine 5% Drop | Lidocaine 2% Jelly | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 6 | 8 | 14 |
| >=65 years | 14 | 12 | 26 |
| Sex: Female, Male(Participants) | Tetracaine 5% Drop | Lidocaine 2% Jelly | Total |
|---|---|---|---|
| Female | 13 | 14 | 27 |
| Male | 7 | 6 | 13 |
| Region of Enrollment(participants) | Tetracaine 5% Drop | Lidocaine 2% Jelly | Total |
|---|---|---|---|
| United States | 20 | 20 | 40 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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