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

NCT ID: NCT03143452

Last Updated: 2018-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-01-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Adult Patients Undergoing Phacoemulsification With Topical Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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lidocaine gel

Lidocaine gel group: received 2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification

Group Type ACTIVE_COMPARATOR

lidocaine gel

Intervention Type DRUG

2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification

tetracaine eye drop

Tetracaine eye drop group: received 0.5% tetracaine eye drop 5 minutes before phacoemulsification

Group Type ACTIVE_COMPARATOR

tetracaine eye drop

Intervention Type DRUG

0.5% tetracaine eye drop was given 5 minutes before phacoemulsification

Interventions

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lidocaine gel

2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification

Intervention Type DRUG

tetracaine eye drop

0.5% tetracaine eye drop was given 5 minutes before phacoemulsification

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Susilo Chandra

Anesthesiologist Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cipto Mangunkusumo Central National Hospital

Jakarta, , Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type BACKGROUND
PMID: 22560419 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20856590 (View on PubMed)

Waheeb S. Topical anesthesia in phacoemulsification. Oman J Ophthalmol. 2010 Sep;3(3):136-9. doi: 10.4103/0974-620X.71892.

Reference Type BACKGROUND
PMID: 21120050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19686592 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26790036 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25675169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15313296 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22915870 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17189801 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14533061 (View on PubMed)

Other Identifiers

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IndonesiaUAnes015

Identifier Type: -

Identifier Source: org_study_id

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