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

Sponsor
TC Erciyes University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05874453
Collaborator
(none)
40
2
12

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: eye care protocol
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Effect of Evidence-Based Eye Care Protocol in Intensive Care Units
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Sep 15, 2023
Anticipated Study Completion Date :
Aug 15, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention Group

Eye care protocol to be appliedevaluation.

Other: 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

No Intervention: Control Group

Routine intensive care Eye care protocol to be applied

Outcome Measures

Primary Outcome Measures

  1. Corneal Changes Rating Scale [the day before the intervention]

    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.

  2. Corneal Changes Rating Scale [5th 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.

  3. 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

  1. Dry Eye Rating Scale [the day before the intervention]

    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

  2. Dry Eye Rating Scale [5th 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • TC Erciyes University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Özlem Ceyhan, Assoc.Prof, TC Erciyes University
ClinicalTrials.gov Identifier:
NCT05874453
Other Study ID Numbers:
  • EYEPROTOCHOL
First Posted:
May 25, 2023
Last Update Posted:
May 25, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Özlem Ceyhan, Assoc.Prof, TC Erciyes University

Study Results

No Results Posted as of May 25, 2023