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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
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine gel | Active Comparator | Lidocaine gel group: received 2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification |
|
| tetracaine eye drop | Active Comparator | Tetracaine eye drop group: received 0.5% tetracaine eye drop 5 minutes before phacoemulsification |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lidocaine gel | Drug | 2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale | assessing subject's pain with visual analog scale | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Additional topical anesthesia requirement | Number of additional topical anesthesia given after the first dose | Day 1 |
| Subjects and surgeon's satisfactory | Assessment is done using questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
Dropout Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cipto Mangunkusumo Central National Hospital | Jakarta | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22560419 | Background | 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. | |
| 20856590 | 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. |
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| tetracaine eye drop | Drug | 0.5% tetracaine eye drop was given 5 minutes before phacoemulsification |
|
| Day 1 |
| 21120050 | Background | Waheeb S. Topical anesthesia in phacoemulsification. Oman J Ophthalmol. 2010 Sep;3(3):136-9. doi: 10.4103/0974-620X.71892. |
| 19686592 | 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. |
| 26790036 | 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. |
| 25675169 | 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. |
| 15313296 | 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. |
| 22915870 | 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. |
| 17189801 | 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. |
| 14533061 | 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. |