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NCT01383200 · ClinicalTrials.gov registry record · Phase 4
Tetracaine Versus Lidocaine Gel for Anesthetic Effect and Comfort in Patients Undergoing LASIK
A Phase 4 study, sponsored by University of Miami.
- Terminated
- Registry status
- Phase 4
- Development phase
- 11
- Enrollment target
NCT01383200 is a Phase 4 study that was terminated before completion, run by University of Miami. The registered enrollment target is 11 participants.
The verdict
NCT01383200, a Phase 4 study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 11 participants
- Enrollment target
Study Summary
In this study the investigators will be comparing two different types of anesthetic, a numbing eye drop and a numbing gel, to test if they are equally effective or if one has a better outcome in terms of the level of comfort you experience one hour and one day after your surgery. The two medications are commonly used and appear to be equally effective for other types of eye surgery, such as cataract surgery. This study will show if one type of anesthesia is preferred over another by patients getting LASIK. Before your LASIK procedure, you will be given a short questionnaire to determine the baseline comfort of your eyes. In the operating room, one type of anesthetic will be put in one eye, and the other medication will be put in the other eye. Which anesthetic you get in each eye will be chosen in a random way (similar to flipping a coin). After your LASIK surgery, the investigators will ask you if you felt more comfort in your right eye, your left eye, or if they were equal, and the investigators will ask you the same survey questions that were asked prior to your LASIK to get more details about your experience. \*Of note- the randomization being done is for which eye will be receiving the lidocaine and which eye will be receiving the tetracaine. Each patient will receive lidocaine in 1 eye and tetracaine in the other eye, the randomization is for each individual eye. This means, of 11 patients in our study, 22 eyes received treatment. 11 eyes received lidocaine and 11 eyes received tetracaine. when we did our comparison, 11 values were used for lidocaine and 11 eyes were used for tetracaine, giving a total of 22 eyes. This is important to note since the randomization refers to EYE for each individual patient, and not for the patient (ie: participant means 1 eye, not 1 person in the descriptions below).
Interventions
- DRUG Lidocaine gel
- DRUG Tetracaine drop
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2011-06 |
| Est. Completion | 2011-10 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01383200
The ClinicalTrials.gov registry entry for NCT01383200 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lidocaine gel is the first listed.
NCT01383200 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01383200 about?
NCT01383200 is a clinical study titled "Tetracaine Versus Lidocaine Gel for Anesthetic Effect and Comfort in Patients Undergoing LASIK". In this study the investigators will be comparing two different types of anesthetic, a numbing eye drop and a numbing gel, to test if they are equally effective or if one has a better outcome in terms of the level of comfort you experience one hour and one day after your surgery. The two medications...
What is the current status of trial NCT01383200?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 11 participants. The study started on 2011-06. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01383200?
The interventions under investigation include: Lidocaine gel (DRUG), Tetracaine drop (DRUG).
Who is sponsoring clinical trial NCT01383200?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
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