Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia

NCT ID: NCT01023334

Last Updated: 2010-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-02-28

Brief Summary

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The purpose of this study is to determine whether intraocular lidocaine increases patient comfort during the different stages of MSICS while under topical anesthesia.

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intraocular lidocaine,topical anesthesia,MSICS

experimental group:manual small incision cataract surgery under topical anesthesia with intracameral lidocaine

Group Type EXPERIMENTAL

MSICS under topical anesthesia with intracameral lidocaine

Intervention Type PROCEDURE

manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral lidocaine

intracameral balanced salt solution,topical anesthesia,MSICS

control group:manual small incision cataract surgery under topical anesthesia with intracameral balanced salt solution.

Group Type EXPERIMENTAL

MSICS under topical anesthesia with intracameral balanced salt solution.

Intervention Type PROCEDURE

manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral balanced salt solution.

Interventions

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MSICS under topical anesthesia with intracameral lidocaine

manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral lidocaine

Intervention Type PROCEDURE

MSICS under topical anesthesia with intracameral balanced salt solution.

manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral balanced salt solution.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Both men and women
* Cataract density grade III-V according to the Emery-Little system classification system
* Patients need to do manual small incision cataract surgery

Exclusion Criteria

* Legal guardian(s) is/are not present for permission
* Any patient with a known sensitivity or allergy to Lidocaine or the "Caine" family of medicines.
* Patients with altered levels of pain perceptions
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

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Eye Hospital, Wenzhou Medical College

Principal Investigators

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Wei Chen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Eye Hospital, Wenzhou Medical College, China

Locations

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Eye Hospital, Wenzhou Medical College

Wenzhou, Zhejiang, China

Site Status

Countries

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China

Other Identifiers

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10002

Identifier Type: -

Identifier Source: org_study_id

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