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

Not Applicable

Recruiting

• Conditions: Eye Protocol; Ocular Complications
• Interventions: Other: eye care protocol

• Registration Number: NCT05874453
• Lead Sponsor: TC Erciyes University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-10
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-05-25
• Status Verified: 2024-02
• Study Start: 2024-03-15
• Primary Completion: 2024-09-15
• Last Update Submitted: 2025-02-27
• Last Update Posted: 2025-03-03
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group	eye care protocol	Eye care protocol to be appliedevaluation.

Primary Outcome Measures

Name	Time	Method
Corneal Changes Rating Scale	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.

Secondary Outcome Measures

Name	Time	Method
Dry Eye Rating Scale	10th day of application	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

Trial Locations

Locations (1)

Erciyes University Hospital; 🇹🇷 Kayseri, Turkey