CClinicalTrials.gg
CompletedNCT00129077Updated Jul 10, 2007

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

An interventional study of plastic wrap over eye & lubrication applied q6 hrs in Eye Injuries and Critically Ill, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Completed at 2 sites in United States. Open to participants aged 2 Weeks to 17 Years. Per ClinicalTrials.gov, last updated 2007-07-10.

Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
207
Allocation
Randomized
Ages
2 Weeks to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Eye Injuries
  • Critically Ill

Keywords

  • Pediatric critical care
  • neuromuscular blocking agents
  • corneal abrasions
03

In context

Corneal Injuries

32 studies on the registry are indexed under Corneal Injuries; 9 are open to participants now.

This study's enrollment of 207 is above the median of 37 across 24 interventional studies indexed under Corneal Injuries.

Browse Corneal Injuries studies →

Lead sponsor

Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 176 studies on the registry; 30 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Weeks to 17 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
207 participants (actual)

Interventions

  • Procedureplastic wrap over eye & lubrication applied q6 hrs
06

What researchers measure

Primary outcomes

  1. Development of corneal abrasions

    Time frame: 9 days

Secondary outcomes

  1. Incidence of corneal abrasions

    Time frame: 36 hours

07

Study locations

2 sites
  • Children's Memorial Hospital
    Chicago, Illinois 60614, United States
  • Children's Hospital Boston
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00129077
Lead sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Boston Children's Hospital, Society of Critical Care Medicine, American Association of Critical Care Nursing
First posted
Aug 11, 2005
Start date
Mar 2004
Completion
Dec 2006
Last update
Jul 10, 2007

Study contacts

Martha AQ Curley, PhD
study chair · Boston Children's Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2007. You cannot join it, but the record below documents what was studied.

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