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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00129077
Enrollment
207
Registered
2005-08-11
Start date
2004-03-31
Completion date
2006-12-31
Last updated
2007-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill, Eye Injuries

Keywords

Pediatric critical care, neuromuscular blocking agents, corneal abrasions

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.

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.

Interventions

PROCEDUREplastic wrap over eye & lubrication applied q6 hrs

Sponsors

Boston Children's Hospital
CollaboratorOTHER
Society of Critical Care Medicine
CollaboratorOTHER
American Association of Critical Care Nursing
CollaboratorUNKNOWN
Ann & Robert H Lurie Children's Hospital of Chicago
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Weeks to 17 Years
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

Design outcomes

Primary

MeasureTime frame
Development of corneal abrasions9 days

Secondary

MeasureTime frame
Incidence of corneal abrasions36 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026