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

NCT01383200 | Terminated Phase 4 Results

• 1 other identifier: 20101016
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain

Keywords

efficacy; comfort

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Tetracaine R/Lidocaine L

ACTIVE COMPARATOR

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

Drug: Tetracaine drop; Drug: Lidocaine gel

Tetracaine L/Lidocaine R

ACTIVE COMPARATOR

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

Drug: Tetracaine drop; Drug: Lidocaine gel

Interventions

Tetracaine drop DRUG

0.5% Tetracaine Right eye / 2% Lidocaine Left eye

Also known as: TetraVisc, Altacaine, AK-T-Caine and Pontocaine Ophthalmic

Tetracaine L/Lidocaine R; Tetracaine R/Lidocaine L

Lidocaine gel DRUG

0.5% Tetracaine Left eye / 2% Lidocaine Right eye

Also known as: Akten

Tetracaine L/Lidocaine R; Tetracaine R/Lidocaine L

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers of age 18 years or greater

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

Related Publications (1)

• 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.

  PMID: 23061994 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Tetracaine; Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Acetanilides; Anilides; Amides; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Sonia Yoo
• Organization: Bascom Palmer Eye Institute

syoo@med.miami.edu

305-243-2020

Study Officials

• SONIA YOO, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PROFESSOR

Study Record Dates

• First Submitted: June 13, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: August 11, 2017
• Results First Posted: April 1, 2015

Record last verified: 2017-06

Locations

US (1)