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

Not Applicable

Completed

• Conditions: Adult Patients Undergoing Phacoemulsification With Topical Anesthesia
• Interventions: Drug: tetracaine eye drop; Drug: lidocaine gel

• Registration Number: NCT03143452
• Lead Sponsor: 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

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 Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-04
• Study First Posted: 2017-05-08
• Primary Completion: 2017-12-01
• Study Completion: 2018-01-31
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-27
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tetracaine eye drop	tetracaine eye drop	Tetracaine eye drop group: received 0.5% tetracaine eye drop 5 minutes before phacoemulsification
lidocaine gel	lidocaine gel	Lidocaine gel group: received 2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification

Primary Outcome Measures

Name	Time	Method
Visual analog scale	Day 1	assessing subject's pain with visual analog scale

Secondary Outcome Measures

Name	Time	Method
Additional topical anesthesia requirement	Day 1	Number of additional topical anesthesia given after the first dose
Subjects and surgeon's satisfactory	Day 1	Assessment is done using questionnaire

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Jakarta, Indonesia