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Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?

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ClinicalTrials.gov Identifier: NCT00129077
Recruitment Status : Completed
First Posted : August 11, 2005
Last Update Posted : July 10, 2007
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to identify the incidence of scratches on the surface of the eye in children who cannot blink due to medication use and to identify how best to reduce the risk of a scratch on the surface of the eye when patients are using specific medicines.

Condition or disease Intervention/treatment
Eye Injuries Critically Ill Procedure: plastic wrap over eye & lubrication applied q6 hrs

Detailed Description:
Critically ill children may require neuromuscular blockade as a treatment modality. These children require careful eye care to prevent corneal abrasions. However, current evidence does not exist to guide best practices on eye care. This research study will evaluate 2 types of eye care therapy. The eyes will be randomly assigned to the control or experimental eye care therapy group. The control eye will receive lubricating ointment every 6 hours. The experimental eye will receive lubricating ointment every 6 hours and have a plastic covering to create a moisture chamber. Using daily fluorescein staining to detect corneal abrasions, each child will be studied for up to 9 days. Children who develop corneal abrasions will be discharged from the study and the primary care team will be notified. The two groups will then be compared to determine the therapy associated with the lowest incidence of corneal abrasions.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?
Study Start Date : March 2004
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Development of corneal abrasions [ Time Frame: 9 days ]

Secondary Outcome Measures :
  1. Incidence of corneal abrasions [ Time Frame: 36 hours ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age greater than 42 weeks post-conceptual age and less than 18 years
  • Anticipated need for neuromuscular blockade therapy for at least 24 hours

Exclusion Criteria:

  • Use of continuous neuromuscular blockade therapy for more than 36 hours (early intervention study)
  • Past medical history of abnormal blink reflex or incomplete lid closure
  • History of daily eye drop use
  • Facial trauma
  • Alteration in periorbital skin integrity prohibiting eyelid closure or effective creation of a moisture chamber
  • Known allergy to eye lubricant
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129077

United States, Illinois
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
Boston Children’s Hospital
Society of Critical Care Medicine
SePA Chapter of the American Association of Critical Care Nurses
Study Chair: Martha AQ Curley, PhD Boston Children’s Hospital
More Information

ClinicalTrials.gov Identifier: NCT00129077     History of Changes
Other Study ID Numbers: 2003-12005
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: July 10, 2007
Last Verified: July 2007

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
Pediatric critical care
neuromuscular blocking agents
corneal abrasions

Additional relevant MeSH terms:
Critical Illness
Eye Injuries
Disease Attributes
Pathologic Processes
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Eye Diseases
Wounds and Injuries