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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859910
• Other study ID #: Lid margin VS Cataract Surgery
• Status: Completed
• Phase: N/A
• First received: May 20, 2013
• Last updated: May 20, 2013
• Start date: October 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2013
• Source: Orbis
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cataract

Intervention

Procedure:
• compression and scrub of lid margin
compression and scrub of lid margin for 5 circles before cataract surgery
• routine preparation for cataract

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Orbis	Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	positive rate of culture		5months	Yes
Secondary	bacteria distribution of the culture		5months	Yes