Lidocaine Usage for Pupil Dilatation (Mydriasis)

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Drug: Lidocaine 1% (sterile)

• Registration Number: NCT01170130
• Lead Sponsor: Carmel Medical Center

Brief Summary

The purpose of this study is to determine if the mydriatic effect of intracameral lidocaine 1% is as effective as topical cyclopentolate 1% and phenylephrine 10% for achieving effective mydriasis during phacoemulsification surgery.

Detailed Description

Former studied done on the effect of Intracameral lidocaine 1% compared to topical mydriatic agents for achieving effective mydriasis during phacoemulsification surgery have compared 2 different groups of patients, ie; One group received topical agents and the other received intracameral lidocaine. The resultant pupil size was recorded and evaluated in the 2 groups. Our purpose is to compare the effect of these agents on the same group of people.

Patients recruited will be invited first for evaluation at least 1 week before the surgery. During this evaluation 1 dose (drop) of topical cyclopentolate 1% and Phenylephrine 10% will be instilled to the evaluated eye 3 times at 10 minutes intervals. After 1 hour from the last instillation pupil diameter will be recorded. In the second part of this study during the phacoemulsification surgery patients will be given intracamerally lidocaine 1% (0.2 ml) and the pupil size will be recorded after 90 seconds. the resultant values will be evaluated/compared.

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-07-13
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• cataract
• men and women
• can read and sign informed consent form

Exclusion Criteria

• sensitivity to Lidocaine
• sensitivity to Ephrine
• any other ocular surgeries
• diseases like Adie's pupil, Horner syndrome

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lidmyd	Lidocaine 1% (sterile)	The same group is used for the first and the second part of the experiment. Initially the patients will be given topical cyclopentolate 1% and Phenylephrine 10% and the pupil diameter will be recorded. In the second part of the experiment lidocaine 1% will be introduced intracamerally and the pupil size will be recorded again. The 2 measurements will be statistically compared/evaluated.

Primary Outcome Measures

Name	Time	Method
Pupil size after mydriatics	no longer then 1 year	We would like to evaluate whether Pupil size dilated with Intracameral Lidocaine 1% is as effective dilator compared with Topical Cyclopentolate 1% and Phenylephrine 10%