Tetracaine Versus Lidocaine Gel for Anesthetic Effect and Comfort in Patients Undergoing LASIK
Information source: University of Miami
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Tetracaine drop (Drug); Lidocaine gel (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: University of Miami Official(s) and/or principal investigator(s): SONIA YOO, MD, Principal Investigator, Affiliation: University of Miami
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).
Clinical Details
Official title: Comparison of 0.5% Tetracaine Drops Versus 2% Lidocaine Gel for Anesthetic Efficacy and Comfort in Patients Undergoing LASIK
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Primary outcome: Participants Score on Pain Scale
Detailed description:
Outcome measures involve comparing the right eye and left eye for severity of 12 different
symptoms, that are recorded in severity on a 1-5 scale. A score of 1 means no symptoms and 5
means severe. The 12 measurements include sharp pain, dull ache, pain during movement,
stinging sensation, itching, light sensitivity, watery eyes, dry eyes, sandy sensation,
pressure sensation, decreased vision, and blurry vision.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- healthy volunteers of age 18 years or greater
Exclusion Criteria:
- Previous reaction/allergy to the same drug class
- prior ocular surgery
- active facial injuries
- any active current ophthalmological disease
- history of diabetes
- any current non- Over The Counter pain medication
- inability to complete the questionnaire.
- Economically or educationally disadvantaged persons, Prisoners, or Children
- Patients with fluctuating or impaired decision-making capacity
- Any other condition that the investigator believes would pose a significant hazard to
the subject if the investigational therapy were initiated
Locations and Contacts
Bascom Palmer Eye Institute, Miami, Florida 33136, United States
Additional Information
Starting date: June 2011
Last updated: March 16, 2015
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