Effect of Evidence-Based Eye Care Protocol in Intensive Care Units
NCT ID: NCT05874453
Last Updated: 2025-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
40 participants
INTERVENTIONAL
2024-03-15
2025-08-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Anisocoria in the Intensive Care Unit (AICU Study)
NCT06964997
Disease Severity, Mortality Risk, and Muscle Function in Intensive Care Unit Patients
NCT07124442
Physical Rehabilitation in ICU in ARDS Patients With COVID-19
NCT04435080
The ICU LIBERATION Study
NCT05844579
Effect of Prone Positioning on Intra-ocular Pressure in ARDS Patients
NCT02711930
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Group
Eye care protocol to be appliedevaluation.
eye care protocol
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
Control Group
Routine intensive care Eye care protocol to be applied
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
eye care protocol
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
TC Erciyes University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Özlem Ceyhan
Assoc.Prof
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Erciyes University Hospital
Kayseri, , Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Özlem Ceyhan, Assoc.Dr.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Ezra 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.
Hartford 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.
Kousha 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.
Mela 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EYEPROTOCHOL
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.