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OpenTrials
Completed

NCT Number: NCT03143452

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

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Central National Hospital

Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine gel

Drug

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

tetracaine eye drop

Drug

0.5% tetracaine eye drop was given 5 minutes before phacoemulsification

Primary outcomes

  1. Visual analog scale

    Time frame: Day 1

    assessing subject's pain with visual analog scale

Secondary outcomes

  1. Additional topical anesthesia requirement

    Time frame: Day 1

    Number of additional topical anesthesia given after the first dose

  2. Subjects and surgeon's satisfactory

    Time frame: Day 1

    Assessment is done using questionnaire

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 8, 2017
Registry last updated
Feb 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.