Pain
Conditions
Keywords
efficacy, comfort
Brief 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).
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.
Interventions
DRUGTetracaine drop
0.5% Tetracaine Right eye / 2% Lidocaine Left eye
DRUGLidocaine gel
0.5% Tetracaine Left eye / 2% Lidocaine Right eye
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants Score on Pain Scale | 1 hour (60minutes) post LASIK operation | Do you have sharp pain in your eye? Pain will be assessed by units on a scale of 1-5: 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort |
Countries
United States
Participant flow
Recruitment details
The recruitment period is now over. Eligible patients included healthy patients undergoing bilateral LASIK surgery.
Participants by arm
| Arm | Count |
|---|---|
| TetracaineRight Eye / LidocaineLeft Eye 0.5% tetracaine drops Right eye /2% lidocaine gel Left eye | 5 |
| TetracaineLeft Eye /LidocaineRight Eye 0.5% tetracaine drops Left eye / 2% lidocaine gel Right eye | 6 |
| Total | 11 |
Baseline characteristics
| Characteristic | TetracaineRight Eye / LidocaineLeft Eye | TetracaineLeft Eye /LidocaineRight Eye | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 6 Participants | 11 Participants |
| Region of Enrollment United States | 5 participants | 6 participants | 11 participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 6 |
Outcome results
Primary
Participants Score on Pain Scale
Do you have sharp pain in your eye? Pain will be assessed by units on a scale of 1-5: 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort
Time frame: 1 hour (60minutes) post LASIK operation
Population: Five participants received tetracaine right eye and lidocaine left eye and six participants received lidocaine right eye and tetracaine left eye. A total of 22 eyes were analyzed for pain.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tetracaine | Participants Score on Pain Scale | 1.95 Score on scale | Standard Deviation 0.75 |
| Lidocaine | Participants Score on Pain Scale | 2.01 Score on scale | Standard Deviation 0.93 |