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

This study has been completed.
Sponsor:
Information provided by:
Wenzhou Medical College
ClinicalTrials.gov Identifier:
NCT01023334
First received: December 1, 2009
Last updated: July 30, 2010
Last verified: December 2009
History of Changes
  Purpose

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


Condition Intervention
Cataract
 Procedure: MSICS under topical anesthesia with intracameral lidocaine
Procedure: MSICS under topical anesthesia with intracameral balanced salt solution.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Intracameral Lidocaine for Manual Small Incision Cataract Surgery Under Topical Anesthesia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Wenzhou Medical College:

Primary Outcome Measures:
  • observed levels of pain [ Time Frame: one day ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: December 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023334

Locations
China, Zhejiang
Eye Hospital, Wenzhou Medical College
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Wenzhou Medical College
Investigators
Principal Investigator: Wei Chen, MD,PhD Eye Hospital, Wenzhou Medical College, China
  More Information

No publications provided

Responsible Party: Wei Chen, Eye Hospital, Wenzhou Medical College
ClinicalTrials.gov Identifier: NCT01023334     History of Changes
Other Study ID Numbers: 10002
Study First Received: December 1, 2009
Last Updated: July 30, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Wenzhou Medical College:
Topical analgesia
FlACC Pain Scale
intracameral lignocaine
 Anesthetics
Physiological Effects of Drugs
Lidocaine

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Anesthetics
Lidocaine
Physiological Effects of Drugs
Central Nervous System Depressants
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013