Cataracts
Conditions
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%.
Interventions
DRUGtetracaine 0.5%
betadine 5%
DRUGLidocaine 2% Jelly
Betadine 5%
Sponsors
Hermann Eye Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tetracaine 5% Drop betadine: betadine 5%
topical anesthetic | 20 |
| Lidocaine 2% Jelly betadine: betadine 5%
anesthetic | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Tetracaine 5% Drop | Lidocaine 2% Jelly | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 12 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 8 Participants | 14 Participants |
| Age, Continuous | 70.0 year STANDARD_DEVIATION 7.4 | 68.4 year STANDARD_DEVIATION 11.8 | 69.2 year STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 13 Participants | 14 Participants | 27 Participants |
| Sex: Female, Male Male | 7 Participants | 6 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine 0.5% Drop | Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs | -0.14 Ln(bacterial colony count) | Standard Deviation 0.67 |
| Lidocaine 2% Jelly | Change in Ln(Bacterial Colony Count) From Pre-antibiotic Administration to Post Study Medication Swabs | -0.52 Ln(bacterial colony count) | Standard Deviation 1.85 |
Primary
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Tetracaine 0.5% Drop | Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs | pre number of bacterial spices | 1 bacterial spceies | Standard Deviation 0 |
| Tetracaine 0.5% Drop | Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs | post surgery number of bacterial speices | 1 bacterial spceies | Standard Deviation 0 |
| Lidocaine 2% Jelly | Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs | pre number of bacterial spices | 1 bacterial spceies | Standard Deviation 0 |
| Lidocaine 2% Jelly | Number of Bacterial Species in Pre-antibiotic Administration and in Post Study Medication Swabs | post surgery number of bacterial speices | 1 bacterial spceies | Standard Deviation 0 |