Ignite Creation Date:
2024-05-05 @ 11:40 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01383200
Status:
TERMINATED
Last Update Posted:
2017-08-11
First Post:
2011-06-13
Brief Title:
Tetracaine Versus Lidocaine Gel for Anesthetic Effect and Comfort in Patients Undergoing LASIK
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Comparison of 05 Tetracaine Drops Versus 2 Lidocaine Gel for Anesthetic Efficacy and Comfort in Patients Undergoing LASIK
Status:
TERMINATED
Status Verified Date:
2017-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
eyes that received gel had slightly thinner than intended flaps
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None