NCT01859910

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
306

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
Last Updated

May 22, 2013

Status Verified

May 1, 2013

Enrollment Period

6 months

First QC Date

May 20, 2013

Last Update Submit

May 20, 2013

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

  • positive rate of culture

    5months

Secondary Outcomes (1)

  • bacteria distribution of the culture

    5months

Study Arms (2)

compression

EXPERIMENTAL

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

Procedure: compression and scrub of lid marginProcedure: routine preparation for cataract

control

ACTIVE COMPARATOR

no compression or scrub of lid margin

Procedure: routine preparation for cataract

Interventions

compression and scrub of lid marginPROCEDURE

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

compression
routine preparation for cataractPROCEDURE
compressioncontrol

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Zhongshan Ophthalmic Center

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 22, 2013

Study Start

October 1, 2011

Primary Completion

April 1, 2012

Study Completion

July 1, 2012

Last Updated

May 22, 2013

Record last verified: 2013-05

Locations

CN(1)