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

NCT ID: NCT01859910

Last Updated: 2013-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-07-31

Brief Summary

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

Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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compression

compression and scrub of lid margin for 5 circles before cataract surgery

Group Type EXPERIMENTAL

compression and scrub of lid margin

Intervention Type PROCEDURE

compression and scrub of lid margin for 5 circles before cataract surgery

routine preparation for cataract

Intervention Type PROCEDURE

control

no compression or scrub of lid margin

Group Type ACTIVE_COMPARATOR

routine preparation for cataract

Intervention Type PROCEDURE

Interventions

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compression and scrub of lid margin

compression and scrub of lid margin for 5 circles before cataract surgery

Intervention Type PROCEDURE

routine preparation for cataract

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role collaborator

Orbis

OTHER

Sponsor Role lead

Responsible Party

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Tiantian Ye

Zhongshan Ophthalmic Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Ophthalmic Center

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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Lid margin VS Cataract Surgery

Identifier Type: -

Identifier Source: org_study_id

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