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

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
MSICS under topical anesthesia with intracameral lidocaine
MSICS under topical anesthesia with intracameral balanced salt solution.
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Topical analgesia, FlACC Pain Scale, intracameral lignocaine, Anesthetics, Physiological Effects of Drugs, Lidocaine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Eye Hospital, Wenzhou Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intraocular lidocaine,topical anesthesia,MSICS

intracameral balanced salt solution,topical anesthesia,MSICS

Arm Description

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

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

Outcomes

Primary Outcome Measures

observed levels of pain

Secondary Outcome Measures

Full Information

First Posted
December 1, 2009
Last Updated
July 30, 2010
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT01023334
Brief Title
Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia
Official Title
Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Wenzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
Topical analgesia, FlACC Pain Scale, intracameral lignocaine, Anesthetics, Physiological Effects of Drugs, Lidocaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intraocular lidocaine,topical anesthesia,MSICS
Arm Type
Experimental
Arm Description
experimental group:manual small incision cataract surgery under topical anesthesia with intracameral lidocaine
Arm Title
intracameral balanced salt solution,topical anesthesia,MSICS
Arm Type
Experimental
Arm Description
control group:manual small incision cataract surgery under topical anesthesia with intracameral balanced salt solution.
Intervention Type
Procedure
Intervention Name(s)
MSICS under topical anesthesia with intracameral lidocaine
Intervention Description
manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral lidocaine
Intervention Type
Procedure
Intervention Name(s)
MSICS under topical anesthesia with intracameral balanced salt solution.
Intervention Description
manual small incision cataract surgery(MSICS) under topical anesthesia with intracameral balanced salt solution.
Primary Outcome Measure Information:
Title
observed levels of pain
Time Frame
one day

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Chen, MD,PhD
Organizational Affiliation
Eye Hospital, Wenzhou Medical College, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Hospital, Wenzhou Medical College
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China

12. IPD Sharing Statement

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

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