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

July 30, 2010 updated by: Wenzhou Medical University
The purpose of this study is to determine whether intraocular lidocaine increases patient comfort during the different stages of MSICS while under topical anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325027
        • Eye Hospital, Wenzhou Medical College

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraocular lidocaine,topical anesthesia,MSICS
experimental group:manual small incision cataract surgery under topical anesthesia with intracameral lidocaine
Procedure: MSICS under topical anesthesia with intracameral lidocaine
manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral lidocaine
Experimental: intracameral balanced salt solution,topical anesthesia,MSICS
control group:manual small incision cataract surgery under topical anesthesia with intracameral balanced salt solution.
Procedure: MSICS under topical anesthesia with intracameral balanced salt solution.
manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral balanced salt solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
observed levels of pain
Time Frame: one day
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wenzhou Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

December 1, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (Estimate)

December 2, 2009

Study Record Updates

Last Update Posted (Estimate)

August 2, 2010

Last Update Submitted That Met QC Criteria

July 30, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cataract

Clinical Trials on MSICS under topical anesthesia with intracameral lidocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Jamaica

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe