Effect of Evidence-Based Eye Care Protocol in Intensive Care Units

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Evidence-Based Eye Care Protocol in Intensive Care Units

Conditions
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Ocular Complications, Eye Protocol

Intervention / Treatment
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* Other: eye care protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Eye care protocol to be appliedevaluation. | Other: eye care protocol<br>* 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<br>|
| No Intervention: Control Group<br>Routine intensive care Eye care protocol to be applied | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 10th day of application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 10th day of application | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eye protocol, ocular complications, intensive care, nursing care