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

Pain Clinical Trial

Official title:

Comparison of 0.5% Tetracaine Drops Versus 2% Lidocaine Gel for Anesthetic Efficacy and Comfort in Patients Undergoing LASIK

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01383200
• Other study ID #: 20101016
• Status: Terminated
• Phase: Phase 4
• First received: June 13, 2011
• Last updated: March 16, 2015
• Start date: June 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2015
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Tetracaine drop
0.5% Tetracaine Right eye / 2% Lidocaine Left eye
• Lidocaine gel
0.5% Tetracaine Left eye / 2% Lidocaine Right eye

Locations

Country	Name	City	State
United States	Bascom Palmer Eye Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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	1 hour (60minutes) post LASIK operation	No