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

Study Overview
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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.

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

Conditions
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Adult Patients Undergoing Phacoemulsification With Topical Anesthesia

Intervention / Treatment
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* Drug: lidocaine gel
* Drug: tetracaine eye drop


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: lidocaine gel<br>Lidocaine gel group: received 2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification | Drug: lidocaine gel<br>* 2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification<br>|
| Active Comparator: tetracaine eye drop<br>Tetracaine eye drop group: received 0.5% tetracaine eye drop 5 minutes before phacoemulsification | Drug: tetracaine eye drop<br>* 0.5% tetracaine eye drop was given 5 minutes before phacoemulsification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale | assessing subject's pain with visual analog scale | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Day 1 |