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

NCT03143452 | Completed

• 1 other identifier: IndonesiaUAnes015
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adult Patients Undergoing Phacoemulsification With Topical Anesthesia

Outcome Measures

Primary Outcomes (1)

• Visual analog scale

  assessing subject's pain with visual analog scale

  Day 1

Secondary Outcomes (2)

• Additional topical anesthesia requirement

  Day 1

• Subjects and surgeon's satisfactory

  Day 1

Study Arms (2)

lidocaine gel

ACTIVE COMPARATOR

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

Drug: lidocaine gel

tetracaine eye drop

ACTIVE COMPARATOR

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

Drug: tetracaine eye drop

Interventions

lidocaine gel DRUG

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

lidocaine gel

tetracaine eye drop DRUG

0.5% tetracaine eye drop was given 5 minutes before phacoemulsification

tetracaine eye drop

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Central National Hospital

Jakarta, 10430, Indonesia

Location

Related Publications (10)

• 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.

  PMID: 22560419 BACKGROUND

• 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.

  PMID: 20856590 BACKGROUND

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

  PMID: 21120050 BACKGROUND

• 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.

  PMID: 19686592 BACKGROUND

• 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.

  PMID: 26790036 BACKGROUND

• 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.

  PMID: 25675169 BACKGROUND

• 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.

  PMID: 15313296 BACKGROUND

• 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.

  PMID: 22915870 BACKGROUND

• 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.

  PMID: 17189801 BACKGROUND

• 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.

  PMID: 14533061 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist Consultant

Study Record Dates

• First Submitted: May 4, 2017
• First Posted: May 8, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 31, 2018
• Last Updated: February 28, 2018

Record last verified: 2018-02

Locations

ID (1)