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

• Sponsor: Orbis (Other)
• Overall Status: Completed
• CT.gov ID: NCT01859910
• Collaborator: Sun Yat-sen University (Other)
• Enrollment: 306
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 34

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	Procedure: compression and scrub of lid margin; Procedure: routine preparation for cataract	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 306 participants
• 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
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Apr 1, 2012
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. positive rate of culture [5months]

Secondary Outcome Measures

1. bacteria distribution of the culture [5months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Zhongshan Ophthalmic Center	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

• Orbis
• Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tiantian Ye, Zhongshan Ophthalmic Center, Orbis
• ClinicalTrials.gov Identifier: NCT01859910
• Other Study ID Numbers: Lid margin VS Cataract Surgery
• First Posted: May 22, 2013
• Last Update Posted: May 22, 2013
• Last Verified: May 1, 2013

• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of May 22, 2013