Corneal DiseasesOCUREA2NCT02348242
Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study of Three Preventive Approaches
A study testing Aqueous Gel, Eyelid Occlusion Dressing and Artificial Tears in people with Corneal Diseases, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
60% of the patients hospitalized in intensive care and sedated suffer from insufficient inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to 57%). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Corneal Diseases
- What is being tested?
- Aqueous Gel, Eyelid Occlusion Dressing and Artificial Tears
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Feb 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult patient
- hospitalized in an intensive care unit
- tracheal intubation and mechanical ventilation since less than 24 hours, with an expected duration of artificial ventilation superior to 72h
Who cannot join
- Patient currently treated by eyedrops for glaucoma
- antecedent of corneal transplant
- ocular prosthesis
Trial locations and contacts
1 site in 1 country.
France1 site
Fondation ophtalmologique Adolphe de Rothschild
Paris, Île-de-France Region, 75019
About this study
Official title: Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study
60% of the patients hospitalized in intensive care and sedated suffer from insufficient inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to 57%). The prevention of such corneal damage can be done using several techniques (artificial tears, eyelid occlusion dressing, aqueous gel). The efficacy of these techniques has never been compared in a rigorous study. Therefore it is not yet possible to determine an evidence-based strategy to prevent corneal damage in intensive care patients.
This study aims at assessing the efficacy of primary prevention of corneal lesions in intensive care patients, in order to elaborate an evidence-based nursing protocol.
- Conditions
- Corneal Diseases
- Being tested
- Aqueous Gel, Eyelid Occlusion Dressing, Artificial Tears
- Keywords
- Intensive care, corneal damage, prevention, nursing protocol
- Medical subject headings
- Corneal Diseases, Corneal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqueous GelDevice
Also called Dexpanthenol® 0.2%
1 drop of Dexpanthenol® 0.2% aqueous gel in the eye every 6 hours
Eyelid Occlusion DressingDevice
Also called Pro-Ophta® Dressing
Eyelid occlusion using pro-ophta® eyelid occlusion dressing, dressing to be verified every 6 hours and replaced daily
Artificial TearsDevice
Also called Phylarm®
1 drop of Phylarm® artificial tears in the eye every 6 hours
| Study group | Role | What they receive |
|---|---|---|
| Aqueous gel | Experimental | In the same patient : one eye receives regular administration of aqueous gel (experimental treatment 1) and the other eye receives regular administration of artificial tears (active comparator) Receives: Device: Aqueous Gel; Device: Artificial Tears |
| Eyelid occlusion dressing | Experimental | In the same patient : one eye is closed with an eyelid closure dressing (experimental treatment 2) and the other eye receives regular administration of artificial tears (active comparator) Receives: Device: Eyelid Occlusion Dressing; Device: Artificial Tears |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of corneal lesions (grade > 0 in the Mercieca classification)
Measured: participants will be followed for the duration of stay in intensive care unit, an expected average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseasesStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Jean-Michel DEVYS, Dr, Principal investigator, Fondation Ophtalomologique Adolphe de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348242
- Sponsor's protocol ID
- 2014-A01197-40
- Acronym
- OCUREA2
- Status last verified
- Feb 2017
- First submitted
- 16 Jan 2015
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Surface Disorders in Patients in Intensive Care Units, a Comparative Study
- ClinicalTrials.gov ID
- NCT02348242
- Acronym / sponsor ID
- OCUREA2 / 2014-A01197-40
- Conditions
- Corneal Diseases
- Keywords
- Intensive care, corneal damage, prevention, nursing protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Dec 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 28 Jan 2015 (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.
60% of the patients hospitalized in intensive care and sedated suffer from insufficient inferior eyelid occlusion. Thus, they are at risk for corneal damage (estimated risk 20% to 57%). The prevention of such corneal damage can be done using several techniques (artificial tears, eyelid occlusion dressing, aqueous gel). The efficacy of these techniques has never been compared in a rigorous study. Therefore it is not yet possible to determine an evidence-based strategy to prevent corneal damage in intensive care patients.
This study aims at assessing the efficacy of primary prevention of corneal lesions in intensive care patients, in order to elaborate an evidence-based nursing protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aqueous gel | Experimental | Device: Aqueous Gel, Device: Artificial TearsIn the same patient : one eye receives regular administration of aqueous gel (experimental treatment 1) and the other eye receives regular administration of artificial tears (active comparator) |
| Eyelid occlusion dressing | Experimental | Device: Eyelid Occlusion Dressing, Device: Artificial TearsIn the same patient : one eye is closed with an eyelid closure dressing (experimental treatment 2) and the other eye receives regular administration of artificial tears (active comparator) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patient
- hospitalized in an intensive care unit
- tracheal intubation and mechanical ventilation since less than 24 hours, with an expected duration of artificial ventilation superior to 72h
Key exclusion criteria (3 listed)
- Patient currently treated by eyedrops for glaucoma
- antecedent of corneal transplant
- ocular prosthesis
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 |
|---|---|---|
| Aqueous GelAlso: Dexpanthenol® 0.2%1 drop of Dexpanthenol® 0.2% aqueous gel in the eye every 6 hours | Device | Aqueous gel |
| Eyelid Occlusion DressingAlso: Pro-Ophta® DressingEyelid occlusion using pro-ophta® eyelid occlusion dressing, dressing to be verified every 6 hours and replaced daily | Device | Eyelid occlusion dressing |
| Artificial TearsAlso: Phylarm®1 drop of Phylarm® artificial tears in the eye every 6 hours | Device | Aqueous gel, Eyelid occlusion dressing |
Primary outcome
Incidence rate of corneal lesions (grade > 0 in the Mercieca classification)
Time frame: participants will be followed for the duration of stay in intensive care unit, an expected average of 1 week
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 13 Feb 2017.
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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.
Jean-Michel DEVYS, Dr principal investigator
Fondation Ophtalomologique Adolphe de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aqueous Gel, Eyelid Occlusion Dressing and Artificial Tears in people with Corneal Diseases, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 3 inclusion and 3 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 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Incidence rate of corneal lesions (grade > 0 in the Mercieca classification) (time frame: participants will be followed for the duration of stay in intensive care unit, an expected average of 1 week). 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 13 Feb 2017; AzTrials last refreshed its copy on 6 Nov 2026.