- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03143452
Comparison Between 2% Lidocaine Gel and 5% Tetracaine Eye Drop as Topical Anesthesia in Phacoemulsification
February 27, 2018 updated by: Susilo Chandra, Indonesia University
This study aimed to compare the efficacy between 2% lidocaine gel vs 0.5% tetracaine eye drop as topical anesthesia in phacoemulsification
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
72
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Jakarta, Indonesia, 10430
- Cipto Mangunkusumo Central National Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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
|
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
|
0.5% tetracaine eye drop was given 5 minutes before phacoemulsification
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale
Time Frame: Day 1
|
assessing subject's pain with visual analog scale
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Additional topical anesthesia requirement
Time Frame: Day 1
|
Number of additional topical anesthesia given after the first dose
|
Day 1
|
Subjects and surgeon's satisfactory
Time Frame: Day 1
|
Assessment is done using questionnaire
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Amiel H, Koch PS. Tetracaine hydrochloride 0.5% versus lidocaine 2% jelly as a topical anesthetic agent in cataract surgery: comparative clinical trial. J Cataract Refract Surg. 2007 Jan;33(1):98-100. doi: 10.1016/j.jcrs.2006.09.013.
- Jinapriya D, Almeida DR, Johnson D, Irrcher I, El-Defrawy SR. Anaesthetic plus dilating gel improves pupil dilation for cataract surgery. Can J Ophthalmol. 2012 Apr;47(2):145-9. doi: 10.1016/j.jcjo.2012.01.007. Epub 2012 Mar 14.
- Tsoumani AT, Asproudis IC, Damigos D. Tetracaine 0.5% eyedrops with or without lidocaine 2% gel in topical anesthesia for cataract surgery. Clin Ophthalmol. 2010 Sep 7;4:967-70. doi: 10.2147/opth.s11755.
- Waheeb S. Topical anesthesia in phacoemulsification. Oman J Ophthalmol. 2010 Sep;3(3):136-9. doi: 10.4103/0974-620X.71892.
- Chalam KV, Murthy RK, Agarwal S, Gupta SK, Grover S. Comparative efficacy of topical tetraVisc versus lidocaine gel in cataract surgery. BMC Ophthalmol. 2009 Aug 17;9:7. doi: 10.1186/1471-2415-9-7.
- Shiroma HF, Shimono KE, Farah ME, Goldhardt R, Grumann A Jr, Rodrigues EB. Comparative Study Between Lidocaine Gel 2% and 5% for Ophthalmic Procedures. J Ocul Pharmacol Ther. 2016 May;32(4):192-5. doi: 10.1089/jop.2015.0002. Epub 2016 Jan 20.
- Rafailov L, Kulak A, Weedon J, Shinder R. Comparison of Lidocaine Gel-Assisted Transconjunctival and Transcutaneous Local Anesthesia for Outpatient Eyelid Surgery. Ophthalmic Plast Reconstr Surg. 2015 Nov-Dec;31(6):470-3. doi: 10.1097/IOP.0000000000000391.
- Soliman MM, Macky TA, Samir MK. Comparative clinical trial of topical anesthetic agents in cataract surgery: lidocaine 2% gel, bupivacaine 0.5% drops, and benoxinate 0.4% drops. J Cataract Refract Surg. 2004 Aug;30(8):1716-20. doi: 10.1016/j.jcrs.2003.12.034.
- Shah H, Reichel E, Busbee B. A novel lidocaine hydrochloride ophthalmic gel for topical ocular anesthesia. Local Reg Anesth. 2010;3:57-63. doi: 10.2147/lra.s6453. Epub 2010 Aug 10.
- Irle S, Luckefahr MH, Tho Seeth T. [Tetracaine drops versus lidocaine gel for topical anaesthesia in cataract surgery]. Klin Monbl Augenheilkd. 2003 Sep;220(9):625-8. doi: 10.1055/s-2003-42811. German.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
December 1, 2017
Study Completion (Actual)
January 31, 2018
Study Registration Dates
First Submitted
May 4, 2017
First Submitted That Met QC Criteria
May 4, 2017
First Posted (Actual)
May 8, 2017
Study Record Updates
Last Update Posted (Actual)
February 28, 2018
Last Update Submitted That Met QC Criteria
February 27, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Pharmaceutical Solutions
- Lidocaine
- Ophthalmic Solutions
- Tetracaine
Other Study ID Numbers
- IndonesiaUAnes015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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