Ocular Surface DiseaseNCT07000565
The Effect of Eye Care With Artificial Tears and Normal Saline on Ocular Surface Disease in Mechanically Ventilated Pediatric Patients
A study testing Eye Care with Artificial Tears and Eye Care with Normal Saline in people with Ocular Surface Disease, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to comparatively examine the effects of eye care practices using artificial tears and normal saline on superficial ocular injuries in pediatric patients receiving mechanical ventilation in the intensive care unit. Read more about this study
- Who is it for?
- Ages 28 days to 18 years
- Conditions the study is for
- Ocular Surface Disease
- What is being tested?
- Eye Care with Artificial Tears and Eye Care with Normal Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 1 Jan 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 28 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 28 days to 18 years
- Receiving invasive mechanical ventilation
- Admitted to the pediatric intensive care unit
- Parent(s) or legal guardian(s) provide informed consent for participation
Who cannot join
- -Having eye-related disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Istanbul Medical Faculty
Istanbul, Istanbul, 34093
About this study
The primary aim of this study is to comparatively examine the effects of eye care practices using artificial tears and normal saline on superficial ocular injuries in pediatric patients receiving mechanical ventilation in the intensive care unit. Based on the findings, the study seeks to provide evidence-based contributions to nursing practices. Additionally, it aims to identify educational strategies to enhance intensive care nurses' knowledge and practice levels and to support the development of clinical care protocols.
H0: There is no difference in the effect of eye care with normal saline and artificial tears on superficial ocular injury in mechanically ventilated pediatric patients.
Read more
H1:Eye care with normal saline is more effective than artificial tears in preventing superficial ocular injury in mechanically ventilated pediatric patients.
H2: Eye care with artificial tears is more effective than normal saline in preventing superficial ocular injury in mechanically ventilated pediatric patients.
- Conditions
- Ocular Surface Disease
- Being tested
- Eye Care with Artificial Tears, Eye Care with Normal Saline
- Keywords
- ocular surface disease, eye care, pediatric intensive care, nursing, artificial tears, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye Care with Artificial TearsOther
Every 2 hours, the artificial tear solution was gently applied to the designated eye for 5 days. The artificial tear product (REFRESH®) contains 5.6 mg of polyvinyl alcohol and 2.4 mg of povidone per mL and is used to maintain ocular surface moisture and reduce irritation.
Eye Care with Normal SalineOther
Every 2 hours, the saline solution(Bio-Fleks brand) was gently applied to the designated eye for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Artificial tears | Experimental | Every 2 hours, artificial tear solution was gently applied to the designated eye. The artificial tear product (REFRESH®) contains 5.6 mg of polyvinyl alcohol and 2.4 mg of povidone per mL and is used to maintain ocular surface moisture and reduce irritation. The eye care procedure was performed over a 5-day period while the patient remained on mechanical ventilation. Receives: Other: Eye Care with Artificial Tears |
| Saline | Active comparator | Every 2 hours, saline solution (Bio-Fleks brand) was gently applied to the assigned eye for saline group.The eye care procedure was performed over a 5-day period while the patient remained on mechanical ventilation. Receives: Other: Eye Care with Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Ocular Dryness Score
Ocular dryness will be measured using the Schirmer test.The score was compared between the eye treated with artificial tears and the eye treated with normal saline.
Measured: Everyday for 5 days after the inclusion of participant
Occurence of Ocular Surface Disease
Florescein testing will be used to evaluate the development of ocular surface disease
Measured: 1 time Everyday for 5 days after the inclusion of participant
Change in Eyelid Closure Degree
Eyelid Closure Degree was evaluated by clinical observation and scoring (e.g., staining intensity and affected area). The score was compared between the eye treated with artificial tears and the eye treated with normal saline.
Measured: 1 time everyday for 5 days after the inclusion of participant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start1 Nov 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface DiseaseStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senanur Şimşek, Marmara University
- Investigators
- Bilgi Gülseven Karabacak, MSc. PhD., Study director, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000565
- Sponsor's protocol ID
- 2855458
- Status last verified
- May 2025
- First submitted
- 24 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Eye Care With Artificial Tears and Normal Saline on Ocular Surface Disease in Mechanically Ventilated Pediatric Patients
- ClinicalTrials.gov ID
- NCT07000565
- Acronym / sponsor ID
- 2855458
- Conditions
- Ocular Surface Disease
- Keywords
- ocular surface disease, eye care, pediatric intensive care, nursing, artificial tears, saline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 3 Jun 2025 (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.
The primary aim of this study is to comparatively examine the effects of eye care practices using artificial tears and normal saline on superficial ocular injuries in pediatric patients receiving mechanical ventilation in the intensive care unit. Based on the findings, the study seeks to provide evidence-based contributions to nursing practices. Additionally, it aims to identify educational strategies to enhance intensive care nurses' knowledge and practice levels and to support the development of clinical care protocols.
H0: There is no difference in the effect of eye care with normal saline and artificial tears on superficial ocular injury in mechanically ventilated pediatric patients.
H1:Eye care with normal saline is more effective than artificial tears in preventing superficial ocular injury in mechanically ventilated pediatric patients.
H2: Eye care with artificial tears is more effective than normal saline in preventing superficial ocular injury in mechanically ventilated pediatric patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artificial tears | Experimental | Other: Eye Care with Artificial TearsEvery 2 hours, artificial tear solution was gently applied to the designated eye. The artificial tear product (REFRESH®) contains 5.6 mg of polyvinyl alcohol and 2.4 mg of povidone per mL and is used to maintain ocular surface moisture and reduce irritation. The eye care procedure was performed over a 5-day period while the patient remained on mechanical ventilation. |
| Saline | Active comparator | Other: Eye Care with Normal SalineEvery 2 hours, saline solution (Bio-Fleks brand) was gently applied to the assigned eye for saline group.The eye care procedure was performed over a 5-day period while the patient remained on mechanical ventilation. |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients aged 28 days to 18 years
- Receiving invasive mechanical ventilation
- Admitted to the pediatric intensive care unit
- Parent(s) or legal guardian(s) provide informed consent for participation
Key exclusion criteria (1 listed)
- -Having eye-related disease
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 with Artificial TearsEvery 2 hours, the artificial tear solution was gently applied to the designated eye for 5 days. The artificial tear product (REFRESH®) contains 5.6 mg of polyvinyl alcohol and 2.4 mg of povidone per mL and is used to maintain ocular surface moisture and reduce irritation. | Other | Artificial tears |
| Eye Care with Normal SalineEvery 2 hours, the saline solution(Bio-Fleks brand) was gently applied to the designated eye for 5 days. | Other | Saline |
Primary outcome
Change in Ocular Dryness Score
Time frame: Everyday for 5 days after the inclusion of participant
Ocular dryness will be measured using the Schirmer test.The score was compared between the eye treated with artificial tears and the eye treated with normal saline.
Occurence of Ocular Surface Disease
Time frame: 1 time Everyday for 5 days after the inclusion of participant
Florescein testing will be used to evaluate the development of ocular surface disease
Change in Eyelid Closure Degree
Time frame: 1 time everyday for 5 days after the inclusion of participant
Eyelid Closure Degree was evaluated by clinical observation and scoring (e.g., staining intensity and affected area). The score was compared between the eye treated with artificial tears and the eye treated with normal saline.
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 3 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Bilgi Gülseven Karabacak, MSc. PhD. study director
Marmara University
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 with Artificial Tears and Eye Care with Normal Saline in people with Ocular Surface Disease, run by Marmara 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 4 inclusion and 1 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 3 Jun 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?
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?
Change in Ocular Dryness Score (time frame: Everyday for 5 days after the inclusion of participant). 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?
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 Jun 2025.