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Comparison Between 2% Lidocaine Gel and 5% Tetracaine Eye Drop as Topical Anesthesia in Phacoemulsification

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ClinicalTrials.gov Identifier: NCT03143452
Recruitment Status : Completed
First Posted : May 8, 2017
Last Update Posted : February 28, 2018
Sponsor:
Information provided by (Responsible Party):
Susilo Chandra, Indonesia University

Brief Summary:
This study aimed to compare the efficacy between 2% lidocaine gel vs 0.5% tetracaine eye drop as topical anesthesia in phacoemulsification

Condition or disease Intervention/treatment Phase
Adult Patients Undergoing Phacoemulsification With Topical Anesthesia Drug: lidocaine gel Drug: tetracaine eye drop Not Applicable

Detailed Description:
Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups (Lidocaine gel and tetracaine eye drop group). Lidocaine group received 2% lidocaine gel in 1 ml syringe, applied to the eye. Tetracaine group received 0.5% tetracaine eye drop. Topical anesthesia was given 5 minutes before phacoemulsification. Five minutes after phacoemulsification finished, visual analog score (VAS) and subjects and surgeon's satisfaction were assessed. Every additional topical anesthesia needed was recorded.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Comparison Between 2% Lidocaine Gel and 5% Tetracaine Eye Drop as Topical Anesthesia in Phacoemulsification
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : December 1, 2017
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: lidocaine gel
Lidocaine gel group: received 2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification
Drug: lidocaine gel
2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification

Active Comparator: tetracaine eye drop
Tetracaine eye drop group: received 0.5% tetracaine eye drop 5 minutes before phacoemulsification
Drug: tetracaine eye drop
0.5% tetracaine eye drop was given 5 minutes before phacoemulsification




Primary Outcome Measures :
  1. Visual analog scale [ Time Frame: Day 1 ]
    assessing subject's pain with visual analog scale


Secondary Outcome Measures :
  1. Additional topical anesthesia requirement [ Time Frame: Day 1 ]
    Number of additional topical anesthesia given after the first dose

  2. Subjects and surgeon's satisfactory [ Time Frame: Day 1 ]
    Assessment is done using questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged more than 40 years old who were planned to undergo elective phacoemulsification with intraocular lens implantation at operating room. The surgery was operated by an experienced ophthalmologist. Subjects had been explained about the study, and agreed to enroll and have signed the informed consent form.

Exclusion Criteria:

  • Subjects with history of allergy to topical anesthesia (2% lidocaine gel and 0.5% tetracaine eye drop), subjects who used another method of intraoperative anesthesia other than topical anesthesia, subjects with history of phacoemulsification before, subjects with difficulty in communication, dementia, and anxiety.

Dropout Criteria:

  • Phacoemulsifications duration more than 30 minutes, and subjects who resigned from the study before the study ended

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143452


Locations
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Indonesia
Cipto Mangunkusumo Central National Hospital
Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University

Publications:

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Responsible Party: Susilo Chandra, Anesthesiologist Consultant, Indonesia University
ClinicalTrials.gov Identifier: NCT03143452     History of Changes
Other Study ID Numbers: IndonesiaUAnes015
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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