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

NCT ID: NCT01383200

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-10-31

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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Tetracaine R/Lidocaine L

Participant's Right or Left eye will receive 0.5% Tetracaine drop, at 10 minutes and 5 minutes, prior to LASIK.

Group Type: ACTIVE_COMPARATOR

Tetracaine drop

Intervention Type: DRUG

0.5% Tetracaine Right eye / 2% Lidocaine Left eye

Lidocaine gel

Intervention Type: DRUG

0.5% Tetracaine Left eye / 2% Lidocaine Right eye

Tetracaine L/Lidocaine R

Participant's Right or Left eye will receive 2% lidocaine gel, at 10 minutes and 5 minutes, prior to LASIK.

Group Type: ACTIVE_COMPARATOR

Tetracaine drop

Intervention Type: DRUG

0.5% Tetracaine Right eye / 2% Lidocaine Left eye

Lidocaine gel

Intervention Type: DRUG

0.5% Tetracaine Left eye / 2% Lidocaine Right eye

Interventions

Tetracaine drop

0.5% Tetracaine Right eye / 2% Lidocaine Left eye

Intervention Type: DRUG

Lidocaine gel

0.5% Tetracaine Left eye / 2% Lidocaine Right eye

Intervention Type: DRUG

Other Intervention Names

TetraVisc, Altacaine, AK-T-Caine and Pontocaine Ophthalmic; Akten

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Sonia Yoo

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SONIA YOO, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Bascom Palmer Eye Institute

Miami, Florida, United States

Countries

United States

References

Shah NV, Vaddavalli PK, Chow JH, Roman JS, Shi W, Yoo SH. Prospective, double-masked, randomized trial comparing lidocaine gel to tetracaine drops in femtosecond laser-assisted LASIK. J Refract Surg. 2012 Oct;28(10):671-2. doi: 10.3928/1081597X-20121001-05. No abstract available.

Reference Type: DERIVED

PMID: 23061994 (View on PubMed)

Other Identifiers

20101016

Identifier Type: -

Identifier Source: org_study_id