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Tetracaine Versus Lidocaine Gel for Anesthetic Effect and Comfort in Patients Undergoing LASIK

NCT01383200 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2017-08-11

Study results available
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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).

Conditions

Interventions

DRUG

Tetracaine drop

0.5% Tetracaine Right eye / 2% Lidocaine Left eye

DRUG

Lidocaine gel

0.5% Tetracaine Left eye / 2% Lidocaine Right eye

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • SONIA YOO, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01383200 on ClinicalTrials.gov