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

This study has been completed.
Sponsor:
Collaborator:
Sun Yat-sen University
Information provided by (Responsible Party):
Tiantian Ye, Orbis
ClinicalTrials.gov Identifier:
NCT01859910
First received: May 20, 2013
Last updated: NA
Last verified: May 2013
History: No changes posted
  Purpose

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


Condition Intervention
Cataract
Procedure: compression and scrub of lid margin
Procedure: routine preparation for cataract

Study Type: Interventional
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
Official Title: Compression of the Lid Margin Increase Microbial Contamination Risk of Patients Undergoing Cataract Surgery

Resource links provided by NLM:


Further study details as provided by Orbis:

Primary Outcome Measures:
  • positive rate of culture [ Time Frame: 5months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • bacteria distribution of the culture [ Time Frame: 5months ] [ Designated as safety issue: Yes ]

Enrollment: 306
Study Start Date: October 2011
Study Completion Date: July 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01859910

Locations
China, Guangdong
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510080
Sponsors and Collaborators
Orbis
Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Tiantian Ye, Zhongshan Ophthalmic Center, Orbis
ClinicalTrials.gov Identifier: NCT01859910     History of Changes
Other Study ID Numbers: Lid margin VS Cataract Surgery
Study First Received: May 20, 2013
Last Updated: May 20, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 15, 2014