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Clinical Trials/NCT01859910
NCT01859910CompletedNot Applicable

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

Orbis1 site in 1 country306 target enrollmentStarted: October 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Orbis
Enrollment
306
Locations
1
Primary Endpoint
positive rate of culture

Study Overview

Brief Summary

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Triple (Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
60 Years to 90 Years (Adult, Older Adult)
Sex
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.

Outcomes

Primary Outcomes

positive rate of culture

Time Frame: 5months

Secondary Outcomes

  • bacteria distribution of the culture(5months)

Investigators

Sponsor
Orbis
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tiantian Ye

Zhongshan Ophthalmic Center

Orbis

Study Sites (1)

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