NCT01023334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2010

Completed
Last Updated

August 2, 2010

Status Verified

December 1, 2009

Enrollment Period

2 months

First QC Date

December 1, 2009

Last Update Submit

July 30, 2010

Conditions

Cataract

Keywords

Topical analgesiaFlACC Pain Scaleintracameral lignocaineAnestheticsPhysiological Effects of DrugsLidocaine

Outcome Measures

Primary Outcomes (1)

  • observed levels of pain

    one day

Study Arms (2)

Intraocular lidocaine,topical anesthesia,MSICS

EXPERIMENTAL

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

Procedure: MSICS under topical anesthesia with intracameral lidocaine

intracameral balanced salt solution,topical anesthesia,MSICS

EXPERIMENTAL

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.

Interventions

MSICS under topical anesthesia with intracameral lidocainePROCEDURE

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

Intraocular lidocaine,topical anesthesia,MSICS
MSICS under topical anesthesia with intracameral balanced salt solution.PROCEDURE

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

intracameral balanced salt solution,topical anesthesia,MSICS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Hospital, Wenzhou Medical College

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Wei Chen, MD,PhD

    Eye Hospital, Wenzhou Medical College, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 1, 2009

First Posted

December 2, 2009

Study Start

December 1, 2009

Primary Completion

February 1, 2010

Study Completion

February 1, 2010

Last Updated

August 2, 2010

Record last verified: 2009-12

Locations

CN(1)