Eye InjuriesNCT00129077
Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?
A study testing plastic wrap over eye & lubrication applied q6 hrs in people with Eye Injuries and Critically Ill, run by Ann & Robert H Lurie Children's Hospital of Chicago at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 2 weeks to 17 years
- Conditions the study is for
- Eye Injuries, Critically Ill
- What is being tested?
- plastic wrap over eye & lubrication applied q6 hrs
- Type of treatment
- Surgery or procedure
- How many people
- 207 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2004to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 weeks to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age greater than 42 weeks post-conceptual age and less than 18 years
- Anticipated need for neuromuscular blockade therapy for at least 24 hours
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital Boston
Boston, Massachusetts, 02115
Children's Memorial Hospital
Chicago, Illinois, 60614
About this study
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.
- Conditions
- Eye Injuries, Critically Ill
- Being tested
- plastic wrap over eye & lubrication applied q6 hrs
- Keywords
- Pediatric critical care, neuromuscular blocking agents, corneal abrasions
- Medical subject headings
- Eye Injuries, Critical Illness, Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plastic wrap over eye & lubrication applied q6 hrsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of corneal abrasions
Measured: 9 days
Secondary outcomes (1)
Incidence of corneal abrasions
Measured: 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study startMar 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Society of Critical Care Medicine, American Association of Critical Care Nurses
- Investigators
- Martha AQ Curley, PhD, Study chair, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129077
- Sponsor's protocol ID
- 2003-12005
- Status last verified
- Jul 2007
- First submitted
- 9 Aug 2005
- Last updated
- 10 Jul 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Use of a Moisture Chamber Decrease the Incidence of Corneal Abrasions in Critically Ill Pediatric Patients?
- ClinicalTrials.gov ID
- NCT00129077
- Acronym / sponsor ID
- 2003-12005
- Conditions
- Eye Injuries, Critically Ill
- Keywords
- Pediatric critical care, neuromuscular blocking agents, corneal abrasions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Society of Critical Care Medicine, American Association of Critical Care Nurses
- Study start
- Mar 2004
- Study completion
- Dec 2006 (actual)
- First posted
- 11 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 weeks to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age greater than 42 weeks post-conceptual age and less than 18 years
- Anticipated need for neuromuscular blockade therapy for at least 24 hours
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| plastic wrap over eye & lubrication applied q6 hrs | Procedure or surgery | – |
Primary outcome
Development of corneal abrasions
Time frame: 9 days
1 secondary outcome
Incidence of corneal abrasions
Time frame: 36 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2007.
Related trials for Eye Injuries
Recruiting
The Effects of Vestibulo-Ocular Reflex Exercises Added to Postural Stabilization Training in Chronic Ankle Instability
Ankle Sprains, Ankle Sprain Strain
Recruiting
Inflammatory Mediators of Glaucoma After Corneal Transplantation (AH-Tears)
Glaucoma, Corneal Transplantation
RecruitingObservational study
The Correlation Between Red Cell Transfusion and Complications of Prematurity
Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD)
Recruiting
Corneal Trauma Diagnostic Study
Ocular Trauma
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Exosomes for NAION
Eye Diseases, Retinitis Pigmentosa
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martha AQ Curley, PhD study chair
Boston Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing plastic wrap over eye & lubrication applied q6 hrs in people with Eye Injuries and Critically Ill, run by Ann & Robert H Lurie Children's Hospital of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of corneal abrasions (time frame: 9 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2007.