Tetracaine Versus Lidocaine Gel for Anesthetic Effect and Comfort in Patients Undergoing LASIK
Condition: Pain
Intervention: Tetracaine drop; Lidocaine gel
Intervention description: 0.5% Tetracaine Right eye / 2% Lidocaine Left eye; 0.5% Tetracaine Left eye / 2% Lidocaine Right eye
Intervention MeSH terms: Lidocaine; Tetracaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: efficacy; comfort

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).
    

Eligibility 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