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Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery

Primary Purpose

Cataract

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

compression and scrub of lid margin

routine preparation for cataract

About this trial

This is an interventional health services research trial for Cataract

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(1) Age > 60 years; (2) clinical diagnosis of age related cataract, without previous recent ocular surgery; (3) undergoing phacoemulsification with implantation of intraocular lens ; (4) able to give informed consent.

Exclusion Criteria:

(1) any inflammation of the eye or other parts of the body within the previous 3 months; (2) chronic use of any types ophthalmic medication; (3) contact lens wear; (4) ocular surgery within the past 3 months; (5) use of systemic antibiotics within 30 days; (6) use of eyedrops in either eye within 3 days of enrollment; (7) need for concurrent glaucoma, cornea or other surgery.

Sites / Locations

Zhongshan Ophthalmic Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

compression

control

Arm Description

compression and scrub of lid margin for 5 circles before cataract surgery

no compression or scrub of lid margin

Outcomes

Primary Outcome Measures

positive rate of culture

Secondary Outcome Measures

bacteria distribution of the culture

Full Information

NCT ID

NCT01859910

First Posted

May 20, 2013

Last Updated

May 20, 2013

Sponsor

Orbis

Collaborators

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT01859910

Brief Title

Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery

Official Title

Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

October 2011 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Orbis

Collaborators

Sun Yat-sen University

4. Oversight

5. Study Description

Brief Summary

To investigate whether compression of the lid margin increase microbial contamination risk of patients undergoing cataract surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cataract

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

306 (Actual)

8. Arms, Groups, and Interventions

Arm Title

compression

Arm Type

Experimental

Arm Description

compression and scrub of lid margin for 5 circles before cataract surgery

Arm Title

control

Arm Type

Active Comparator

Arm Description

no compression or scrub of lid margin

Intervention Type

Procedure

Intervention Name(s)

compression and scrub of lid margin

Intervention Description

compression and scrub of lid margin for 5 circles before cataract surgery

Intervention Type

Procedure

Intervention Name(s)

routine preparation for cataract

Primary Outcome Measure Information:

Title

positive rate of culture

Time Frame

5months

Secondary Outcome Measure Information:

Title

bacteria distribution of the culture

Time Frame

5months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: (1) Age > 60 years; (2) clinical diagnosis of age related cataract, without previous recent ocular surgery; (3) undergoing phacoemulsification with implantation of intraocular lens ; (4) able to give informed consent. Exclusion Criteria: (1) any inflammation of the eye or other parts of the body within the previous 3 months; (2) chronic use of any types ophthalmic medication; (3) contact lens wear; (4) ocular surgery within the past 3 months; (5) use of systemic antibiotics within 30 days; (6) use of eyedrops in either eye within 3 days of enrollment; (7) need for concurrent glaucoma, cornea or other surgery.

Facility Information:

Facility Name

Zhongshan Ophthalmic Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

12. IPD Sharing Statement

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Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery

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