Effects of Two Different Eye Care Practices on Eye Complications in Mechanically Ventilated Intensive Care Patients
1 other identifier
interventional
156
1 country
1
Brief Summary
This study was designed as a prospective, randomized controlled experimental study aiming to compare different approaches to eye care in intensive care patients receiving mechanical ventilation. In this study, patients receiving mechanical ventilation in the intensive care unit will be randomly assigned to four groups using a simple randomization method:
- 1.Control Group: Standard Eye Care
- 2.Intervention Group 1: Eye Care with Eye Care Kit
- 3.Intervention Group 2: Eye Care According to Eye Care Protocol
- 4.Intervention Group 3: Eye Care with Both Protocol and Eye Care Kit Research Hypotheses H1: Eye care provided using a care protocol is more effective in preventing the development of complications compared to standard eye care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2025
CompletedStudy Start
First participant enrolled
July 1, 2025
CompletedFirst Posted
Study publicly available on registry
July 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
January 29, 2026
January 1, 2026
10 months
June 20, 2025
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Conjunctival Edema in Critically Ill Patients
Conjunctival Edema (Chemosis): Chemosis is the edema of the conjunctiva, which is a thin, transparent membrane covering the inner surface of the eyelids and the white part of the eyes (sclera). It refers to the swelling of this membrane that lines the ocular surface.
Data collection was conducted for 10 consecutive days, beginning 24 hours after admission to the intensive care unit.
Ocular Infections in Critically Ill Patients
Signs and Symptoms of Ocular Infection: Redness, ocular discharge, crusting along the eyelid margins, adhesion of eyelashes (eyelashes sticking together), corneal discoloration (loss of corneal transparency), periorbital edema.
Data collection was conducted for 10 consecutive days, beginning 24 hours after admission to the intensive care unit.
Dry Eye in Critically Ill Patients
Dry Eye: Dry eye is a multifactorial disease of the ocular surface, defined by tear film instability and associated with symptoms including ocular discomfort, burning sensation, irritation, dryness, visual blurring, and foreign body sensation."
Data collection was conducted for 10 consecutive days, beginning 24 hours after admission to the intensive care unit.
Study Arms (4)
Control Group: Standard Eye Care Group
EXPERIMENTALThere is no established protocol or guideline for eye care in the intensive care unit where the study will be conducted. Routine eye care involves the use of sterile gauze and sterile saline. During routine suctioning procedures, patients' eyes are not closed. If a patient is unable to achieve full eyelid closure, their eyes are covered with an eye patch or sterile gauze. The Schirmer test will be administered to both eyes on the first day (prior to the first eye care intervention), as well as on the fifth, seventh, and tenth days after eye care is performed. Signs and symptoms of eye infection and chemosis will be evaluated daily after the second eye care procedure. Data for this group will be collected, and the administration and documentation of eye care will be monitored.
Intervention Group 1: Eye Care Using an Eye Care Kit
EXPERIMENTALEye care will be performed using an eye care kit. All nursing staff in the intensive care unit will receive training regarding the contents and usage of the kit. Patients in this group will receive eye care solely using the kit, following a 4-times-daily care protocol. For patients with lagophthalmos, eyes will be covered using the eye closure pad provided in the kit. The Schirmer test will be performed on both eyes on the first day prior to the initial eye care intervention, and on the fifth, seventh, and tenth days following eye care, with results recorded. Signs of infection and chemosis will be assessed daily after the second eye care session. Data collection will be done using , and eye care administration will be tracked.
Intervention Group 2: Eye Care According to an Eye Care Protocol
EXPERIMENTALAll ICU nursing staff will be educated on the eye care protocol. A copy of the protocol will be posted on the doors of the rooms of patients receiving care under the protocol. Patients' ocular risk factors will be assessed daily, followed by eye care based on the protocol. Changes in ocular condition will be assessed and documented, and ICU physicians will be informed as necessary. In cases of incomplete eyelid closure, eyes will be covered upon physician notification. Patients will be assessed daily for signs of eye infection and conjunctival edema in accordance with the protocol. If signs of infection or complications occur during the day, they will be marked with a (+) symbol on the form. The Schirmer test will be applied on the first day (prior to the initial eye care session) and after eye care on days 5, 7, and 10, with results documented.
Intervention Group 3: Eye Care Using Both the Eye Care Protocol and the Eye Care Kit
EXPERIMENTALICU nursing staff will be educated on the eye care protocol. A copy of the protocol will be posted on the doors of the rooms of patients receiving this combined care. Eye care will be performed using the Eye Care Kit developed by the researchers in accordance with the protocol. Patients will be assessed for ocular risk factors daily, and eye care will be provided according to the management guidelines of the protocol. In cases of incomplete eyelid closure, the eyes will be covered with physician knowledge. Patients will be assessed daily for signs of infection and conjunctival edema as per the protocol. Any signs of infection or complications will be marked with a (+) on the form. The Schirmer test will be performed on both eyes before the first eye care session on day 1, and following eye care on days 5, 7, and 10, with results recorded.
Interventions
There is no established protocol or guideline for eye care in the intensive care unit where the study will be conducted. Routine eye care involves the use of sterile gauze and sterile saline. During routine suctioning procedures, patients' eyes are not closed. If a patient is unable to achieve full eyelid closure, their eyes are covered with an eye patch or sterile gauze. The Schirmer test will be administered to both eyes on the first day (prior to the first eye care intervention), as well as on the fifth, seventh, and tenth days after eye care is performed. Signs and symptoms of eye infection and chemosis will be evaluated daily after the second eye care procedure. Data for this group will be collected, and the administration and documentation of eye care will be monitored.
* All ICU nursing staff will be educated on the eye care protocol. A copy of the protocol will be posted on the doors of the rooms of patients receiving care under the protocol. * Patients' ocular risk factors will be assessed daily, followed by eye care based on the protocol. * Changes in ocular condition will be assessed and documented, and ICU physicians will be informed as necessary. * In cases of incomplete eyelid closure, eyes will be covered upon physician notification. * Patients will be assessed daily for signs of eye infection and conjunctival edema in accordance with the protocol. If signs of infection or complications occur during the day, they will be marked with a (+) symbol on the form. * The Schirmer test will be applied on the first day (prior to the initial eye care session) and after eye care on days 5, 7, and 10, with results documented.
* ICU nursing staff will be educated on the eye care protocol. A copy of the protocol will be posted on the doors of the rooms of patients receiving this combined care. * Eye care will be performed using the Eye Care Kit developed by the researchers in accordance with the protocol. * Patients will be assessed for ocular risk factors daily, and eye care will be provided according to the management guidelines of the protocol. * In cases of incomplete eyelid closure, the eyes will be covered with physician knowledge. * Patients will be assessed daily for signs of infection and conjunctival edema as per the protocol. Any signs of infection or complications will be marked with a (+) on the form. * The Schirmer test will be performed on both eyes before the first eye care session on day 1, and following eye care on days 5, 7, and 10, with results recorded.
Eye care will be performed using an eye care kit. All nursing staff in the intensive care unit will receive training regarding the contents and usage of the kit. Patients in this group will receive eye care solely using the kit, following a 4-times-daily care protocol. For patients with lagophthalmos, eyes will be covered using the eye closure pad provided in the kit. The Schirmer test will be performed on both eyes on the first day prior to the initial eye care intervention, and on the fifth, seventh, and tenth days following eye care, with results recorded. Signs of infection and chemosis will be assessed daily after the second eye care session. Data collection will be done using , and eye care administration will be tracked.
Eligibility Criteria
You may qualify if:
- Age 18 years or older
- Receiving mechanical ventilation
- Glasgow Coma Scale (GCS) score \< 12
- At least 24 hours have passed since ICU admission
You may not qualify if:
- Diagnosed with brain death
- Presence of facial or ocular trauma
- Patients with head trauma
- Patients who have undergone brain surgery
- Patients diagnosed with an eye infection or chemosis
- Withdrawal Criteria:
- Patient's death during the study period
- Extubation of the patient before completion of the care period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Health Sciences (Sağlık Bilimleri Üniversitesi)
Istanbul, Istanbul, 34668, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yildiz Deniz
University of Health Sciences (Sağlık Bilimleri Üniversitesi)
- STUDY DIRECTOR
Besey Oren
University of Health Sciences (Sağlık Bilimleri Üniversitesi)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
June 20, 2025
First Posted
July 17, 2025
Study Start
July 1, 2025
Primary Completion (Estimated)
May 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- IPD and related documents will be available starting 6 months after the primary results are published and will remain accessible for up to 5 years from that date.
- Access Criteria
- Access will be granted to qualified researchers for academic, non-commercial research purposes. Interested researchers must submit a methodologically sound proposal and obtain approval from the study's data access committee. All data will be shared in a de-identified format via secure transfer. The applicant must agree to a data use agreement ensuring data confidentiality and ethical use.
Individual participant data (IPD) that underlie the results reported in publications derived from this study will be made available to qualified researchers. Shared data will include de-identified datasets and related data dictionaries.