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

May 20, 2013 updated by: Tiantian Ye, Orbis
To investigate whether compression of the lid margin increase microbial contamination risk of patients undergoing cataract surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

306

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Zhongshan Ophthalmic Center

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

60 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: compression
compression and scrub of lid margin for 5 circles before cataract surgery
Procedure: compression and scrub of lid margin
compression and scrub of lid margin for 5 circles before cataract surgery
Procedure: routine preparation for cataract
ACTIVE_COMPARATOR: control
no compression or scrub of lid margin
Procedure: routine preparation for cataract

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
positive rate of culture
Time Frame: 5months
5months

Secondary Outcome Measures

Outcome Measure
Time Frame
bacteria distribution of the culture
Time Frame: 5months
5months

Collaborators and Investigators

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

Sponsor

Orbis

Collaborators

Sun Yat-sen 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

October 1, 2011

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

May 20, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (ESTIMATE)

May 22, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

May 22, 2013

Last Update Submitted That Met QC Criteria

May 20, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Lid margin VS Cataract Surgery

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.

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