Ocular ComplicationsNCT05874453
Effect of Evidence-Based Eye Care Protocol in Intensive Care Units
A study testing eye care protocol in people with Ocular Complications and Eye Protocol, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
In intensive care patients, normal eye protection mechanisms such as tear production, blinking and keeping the eyes closed are impaired. If eye-related complications are not diagnosed and treated in time, they can cause microbial keratitis and vision loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Complications, Eye Protocol
- What is being tested?
- eye care protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2024to 15 Aug 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients connected to mechanical ventilator,
- Newly intubated patients,
- Patients who have not been diagnosed with keratopathy and keratoconjunctivitis as of hospitalization,
- Patients who have not been diagnosed with burns and facial injuries,
- Patients without chronic lagophthalmos and eye trauma before ICU admission
Who cannot join
- Patients who have received topical drug therapy other than ocular lubrication
- Patients with muscle weakness as a result of cranial nerve VII (facial) nerve palsy
- Patients with chronic lagophthalmos and eye infections
- Those with rheumatological diseases
- Those with neurological/neuropathic disease that will affect eye closure
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erciyes University Hospital
Kayseri, 38039
Özlem Ceyhan, Assoc.Dr.
About this study
In intensive care patients, normal eye protection mechanisms such as tear production, blinking and keeping the eyes closed are impaired.
If eye-related complications are not diagnosed and treated in time, they can cause microbial keratitis and vision loss. This study was planned as a randomized controlled experimental study to examine the effect of using an evidence-based protocol on eye care on ophthalmologic complications. Patients who meet the inclusion criteria will be randomized, and one eye of the patients will be assigned to the intervention group (experimental group) and the other to the control group. When the study reaches 40 patients, G*Power analysis will be applied and the sample size will be decided according to the result.
- Conditions
- Ocular Complications, Eye Protocol
- Being tested
- eye care protocol
- Keywords
- eye protocol, ocular complications, intensive care, nursing care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eye care protocolOther
The lower conjunctiva of the eye to be treated is opened, 1-2 drops of gel are applied, the eye is closed. Cleaning eye secretions is done with sterile distilled water. A gel containing trehalose, hyaluronic acid and carbomer will be applied every 2-4 hours in accordance with intensive care eye care protocol. In order to determine the exposure keratopathy, staining with Fluorescein Sodium will be performed by the ophthalmologist on days 0, 5 and 10, and a blue light pen will be used for evaluation. In order to determine the degree of dry eye, the Schirmer I test will be performed on the 0th and 10th days
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Eye care protocol to be appliedevaluation. Receives: Other: eye care protocol |
| Control Group | No intervention | Routine intensive care Eye care protocol to be applied |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Changes Rating Scale
It is the diagnosis of ocular surface/corneal epithelial damage and dry eye syndrome by instillation of fluorescein sodium, which is used to determine corneal surface damage. A patient is considered to have exposure keratopathy if either eye has a grade greater than 0.
Measured: the day before the intervention
Corneal Changes Rating Scale
It is the diagnosis of ocular surface/corneal epithelial damage and dry eye syndrome by instillation of fluorescein sodium, which is used to determine corneal surface damage. A patient is considered to have exposure keratopathy if either eye has a grade greater than 0.
Measured: 5th day of application
Corneal Changes Rating Scale
It is the diagnosis of ocular surface/corneal epithelial damage and dry eye syndrome by instillation of fluorescein sodium, which is used to determine corneal surface damage. A patient is considered to have exposure keratopathy if either eye has a grade greater than 0.
Measured: 10th day of application
Secondary outcomes (3)
Dry Eye Rating Scale
The Schirmer I test is performed by placing the strip on the lower eyelid margin approximately 2 mm from the lateral canthus, away from the cornea. The eyelid is closed for five minutes and the wet portion of the strip is measured in millimeters. Values greater than 10 mm/5 minutes indicate the normal volume of the tear film
Measured: the day before the intervention
Dry Eye Rating Scale
The Schirmer I test is performed by placing the strip on the lower eyelid margin approximately 2 mm from the lateral canthus, away from the cornea. The eyelid is closed for five minutes and the wet portion of the strip is measured in millimeters. Values greater than 10 mm/5 minutes indicate the normal volume of the tear film
Measured: 5th day of application
Dry Eye Rating Scale
The Schirmer I test is performed by placing the strip on the lower eyelid margin approximately 2 mm from the lateral canthus, away from the cornea. The eyelid is closed for five minutes and the wet portion of the strip is measured in millimeters. Values greater than 10 mm/5 minutes indicate the normal volume of the tear film
Measured: 10th day of application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start15 Mar 2024
- Primary completion15 Sep 2024
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ocular ComplicationsStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Ceyhan, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874453
- Sponsor's protocol ID
- EYEPROTOCHOL
- Status last verified
- Feb 2024
- First submitted
- 10 May 2023
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
El Hachimi R, El Hadiri R, Benchekroun S, Boutimzine N, Amazouzi A, Cherkaoui LO, Maazouzi AW. [Incidence and risk factors of exposure keratopathy in intensive care units: About 91 patients]. J Fr Ophtalmol. 2022 Dec;45(10):1137-1143. doi: 10.1016/j.jfo.2022.03.009. Epub 2022 Oct 29. French.
PubMed 36319529Ezra DG, Chan MP, Solebo L, Malik AP, Crane E, Coombes A, Healy M. Randomised trial comparing ocular lubricants and polyacrylamide hydrogel dressings in the prevention of exposure keratopathy in the critically ill. Intensive Care Med. 2009 Mar;35(3):455-61. doi: 10.1007/s00134-008-1284-4. Epub 2008 Sep 23.
PubMed 18810388Hartford JB, Bian Y, Mathews PM, De Rojas J, Garg A, Rasool N, Schroder SK, Trief D. Prevalence and Risk Factors of Exposure Keratopathy Across Different Intensive Care Units. Cornea. 2019 Sep;38(9):1124-1130. doi: 10.1097/ICO.0000000000001961.
PubMed 31394552Kousha O, Kousha Z, Paddle J. Exposure keratopathy: Incidence, risk factors and impact of protocolised care on exposure keratopathy in critically ill adults. J Crit Care. 2018 Apr;44:413-418. doi: 10.1016/j.jcrc.2017.11.031. Epub 2017 Nov 28.
PubMed 29353117Mela EK, Drimtzias EG, Christofidou MK, Filos KS, Anastassiou ED, Gartaganis SP. Ocular surface bacterial colonisation in sedated intensive care unit patients. Anaesth Intensive Care. 2010 Jan;38(1):190-3. doi: 10.1177/0310057X1003800129.
PubMed 20191796
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Evidence-Based Eye Care Protocol in Intensive Care Units
- ClinicalTrials.gov ID
- NCT05874453
- Acronym / sponsor ID
- EYEPROTOCHOL
- Conditions
- Ocular Complications, Eye Protocol
- Keywords
- eye protocol, ocular complications, intensive care, nursing care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 25 May 2023 (actual)
- 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.
In intensive care patients, normal eye protection mechanisms such as tear production, blinking and keeping the eyes closed are impaired.
If eye-related complications are not diagnosed and treated in time, they can cause microbial keratitis and vision loss. This study was planned as a randomized controlled experimental study to examine the effect of using an evidence-based protocol on eye care on ophthalmologic complications. Patients who meet the inclusion criteria will be randomized, and one eye of the patients will be assigned to the intervention group (experimental group) and the other to the control group. When the study reaches 40 patients, G*Power analysis will be applied and the sample size will be decided according to the result.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: eye care protocolEye care protocol to be appliedevaluation. |
| Control Group | No intervention | –Routine intensive care Eye care protocol to be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients connected to mechanical ventilator,
- Newly intubated patients,
- Patients who have not been diagnosed with keratopathy and keratoconjunctivitis as of hospitalization,
- Patients who have not been diagnosed with burns and facial injuries,
- Patients without chronic lagophthalmos and eye trauma before ICU admission
Key exclusion criteria (5 listed)
- Patients who have received topical drug therapy other than ocular lubrication
- Patients with muscle weakness as a result of cranial nerve VII (facial) nerve palsy
- Patients with chronic lagophthalmos and eye infections
- Those with rheumatological diseases
- Those with neurological/neuropathic disease that will affect eye closure
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 |
|---|---|---|
| eye care protocolThe lower conjunctiva of the eye to be treated is opened, 1-2 drops of gel are applied, the eye is closed. Cleaning eye secretions is done with sterile distilled water. A gel containing trehalose, hyaluronic acid and carbomer will be applied every 2-4 hours in accordance with intensive care eye care protocol. In order to determine the exposure keratopathy, staining with Fluorescein Sodium will be performed by the ophthalmologist on days 0, 5 and 10, and a blue light pen will be used for evaluation. In order to determine the degree of dry eye, the Schirmer I test will be performed on the 0th and 10th days | Other | Intervention Group |
Primary outcome
Corneal Changes Rating Scale
Time frame: the day before the intervention
It is the diagnosis of ocular surface/corneal epithelial damage and dry eye syndrome by instillation of fluorescein sodium, which is used to determine corneal surface damage. A patient is considered to have exposure keratopathy if either eye has a grade greater than 0.
Corneal Changes Rating Scale
Time frame: 5th day of application
It is the diagnosis of ocular surface/corneal epithelial damage and dry eye syndrome by instillation of fluorescein sodium, which is used to determine corneal surface damage. A patient is considered to have exposure keratopathy if either eye has a grade greater than 0.
Corneal Changes Rating Scale
Time frame: 10th day of application
It is the diagnosis of ocular surface/corneal epithelial damage and dry eye syndrome by instillation of fluorescein sodium, which is used to determine corneal surface damage. A patient is considered to have exposure keratopathy if either eye has a grade greater than 0.
3 secondary outcomes
Dry Eye Rating Scale
Time frame: the day before the intervention
Dry Eye Rating Scale
Time frame: 5th day of application
Dry Eye Rating Scale
Time frame: 10th day of application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Background: PubMed 36319529El Hachimi R, El Hadiri R, Benchekroun S, Boutimzine N, Amazouzi A, Cherkaoui LO, Maazouzi AW. [Incidence and risk factors of exposure keratopathy in intensive care units: About 91 patients]. J Fr Ophtalmol. 2022 Dec;45(10):1137-1143. doi: 10.1016/j.jfo.2022.03.009. Epub 2022 Oct 29. French.
- Background: PubMed 18810388Ezra DG, Chan MP, Solebo L, Malik AP, Crane E, Coombes A, Healy M. Randomised trial comparing ocular lubricants and polyacrylamide hydrogel dressings in the prevention of exposure keratopathy in the critically ill. Intensive Care Med. 2009 Mar;35(3):455-61. doi: 10.1007/s00134-008-1284-4. Epub 2008 Sep 23.
- Background: PubMed 31394552Hartford JB, Bian Y, Mathews PM, De Rojas J, Garg A, Rasool N, Schroder SK, Trief D. Prevalence and Risk Factors of Exposure Keratopathy Across Different Intensive Care Units. Cornea. 2019 Sep;38(9):1124-1130. doi: 10.1097/ICO.0000000000001961.
- Background: PubMed 29353117Kousha O, Kousha Z, Paddle J. Exposure keratopathy: Incidence, risk factors and impact of protocolised care on exposure keratopathy in critically ill adults. J Crit Care. 2018 Apr;44:413-418. doi: 10.1016/j.jcrc.2017.11.031. Epub 2017 Nov 28.
- Background: PubMed 20191796Mela EK, Drimtzias EG, Christofidou MK, Filos KS, Anastassiou ED, Gartaganis SP. Ocular surface bacterial colonisation in sedated intensive care unit patients. Anaesth Intensive Care. 2010 Jan;38(1):190-3. doi: 10.1177/0310057X1003800129.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eye care protocol in people with Ocular Complications and Eye Protocol, run by TC Erciyes University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Mar 2025. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özlem Ceyhan, Assoc.Prof. (+903522076666 ext. 28561, ozlemg@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal Changes Rating Scale (time frame: the day before the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05874453, which also lists 5 linked publications.
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 3 Mar 2025.