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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01859910
First Posted: May 22, 2013
Last Update Posted: May 22, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Tiantian Ye, Orbis
  Purpose
To investigate whether compression of the lid margin increase microbial contamination risk of patients undergoing cataract surgery

Condition Intervention
Cataract Procedure: compression and scrub of lid margin Procedure: routine preparation for cataract

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Tiantian Ye, Orbis:

Primary Outcome Measures:
  • positive rate of culture [ Time Frame: 5months ]

Secondary Outcome Measures:
  • bacteria distribution of the culture [ Time Frame: 5months ]

Enrollment: 306
Study Start Date: October 2011
Study Completion Date: July 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859910


Locations
China, Guangdong
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Orbis
Sun Yat-sen University
  More Information

Responsible Party: Tiantian Ye, Zhongshan Ophthalmic Center, Orbis
ClinicalTrials.gov Identifier: NCT01859910     History of Changes
Other Study ID Numbers: Lid margin VS Cataract Surgery
First Submitted: May 20, 2013
First Posted: May 22, 2013
Last Update Posted: May 22, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases