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

This study has been terminated.
(eyes that received gel had slightly thinner than intended flaps)
Sponsor:
Information provided by (Responsible Party):
Nisha Shah, University of Miami
ClinicalTrials.gov Identifier:
NCT01383200
First received: June 13, 2011
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Pain
Drug: 2% lidocaine gel
Drug: 0.5% tetracaine drops
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison of 0.5% Tetracaine Drops Versus 2% Lidocaine Gel for Anesthetic Efficacy and Comfort in Patients Undergoing LASIK

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • sharp pain [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    Do you have sharp pain in your eye? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort

  • dull pain [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    Do you have dull or blunt pain in your eye? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort

  • pain during movement [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    Do you have pain in your eye when you look up, down, right, and/or left? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort

  • stinging sensation [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    Do your eyes sting? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort

  • Itching [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    Do your eyes itch? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort

  • light sensitivity [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    does bright light hurt your eyes? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort.

  • watery eyes [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    are your eyes more watery than usual? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort.

  • dry eyes [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    Do your eyes feel dry? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort.

  • Sandy Sensation [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    Does it feel like there is sand in your eyes? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort.

  • Pressure Sensation [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    Do you feel pressure in your eyes? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort.

  • Decreased Vision [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    Is it difficult to see? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort.

  • Blurry Vision [ Time Frame: 1hr-1day ] [ Designated as safety issue: No ]
    Is your vision blurry? It will be assessed via a 1-5 scale. 1 means no symptoms, 2 means slight discomfort, 3 means mild discomfort, 4 means moderate discomfort, and 5 means severe discomfort.


Enrollment: 11
Study Start Date: June 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: tetracaine
0.5% tetracaine drops
Drug: 2% lidocaine gel
2% lidocaine gel
Active Comparator: lidocaine
2% lidocaine gel
Drug: 0.5% tetracaine drops
0.5% tetracaine drops

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383200

Locations
United States, Florida
Bascom Palmer Eye Institute
Miami, Florida, United States, U
Sponsors and Collaborators
University of Miami
  More Information

No publications provided by University of Miami

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nisha Shah, MD Student, University of Miami
ClinicalTrials.gov Identifier: NCT01383200     History of Changes
Other Study ID Numbers: 20101016
Study First Received: June 13, 2011
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Miami:
efficacy
comfort

Additional relevant MeSH terms:
Lidocaine
Tetracaine
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014