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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05874453
Enrollment
40
Registered
2023-05-25
Start date
2024-03-15
Completion date
2025-08-15
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eye Protocol, Ocular Complications

Keywords

eye protocol, ocular complications, intensive care, nursing care

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.

Interventions

OTHEReye 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

Sponsors

TC Erciyes University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Corneal Changes Rating Scalethe day before the interventionIt 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

MeasureTime frameDescription
Dry Eye Rating Scalethe day before the interventionThe 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

Countries

Turkey (Türkiye)

Contacts

Primary ContactÖzlem Ceyhan, Assoc.Prof.
ozlemg@erciyes.edu.tr+903522076666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026