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

NCT05874453 | Recruiting

• 1 other identifier: EYEPROTOCHOL
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Complications; Eye Protocol

Keywords

eye protocol; ocular complications; intensive care; nursing care

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Dry Eye Rating Scale

  the day before the intervention

• Dry Eye Rating Scale

  5th day of application

• Dry Eye Rating Scale

  10th day of application

Study Arms (2)

Intervention Group

EXPERIMENTAL

Eye care protocol to be appliedevaluation.

Other: eye care protocol

Control Group

NO INTERVENTION

Routine intensive care Eye care protocol to be applied

Interventions

eye care protocol OTHER

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

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Erciyes University Hospital

Kayseri, 38039, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 36319529 BACKGROUND

• 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.

  PMID: 18810388 BACKGROUND

• 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.

  PMID: 31394552 BACKGROUND

• 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.

  PMID: 29353117 BACKGROUND

• 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.

  PMID: 20191796 BACKGROUND

Central Study Contacts

Özlem Ceyhan, Assoc.Prof.

CONTACT

+903522076666; ozlemg@erciyes.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.Prof

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: May 25, 2023
• Study Start: March 15, 2024
• Primary Completion: September 15, 2024
• Study Completion: August 15, 2025
• Last Updated: March 3, 2025

Record last verified: 2024-02

Locations

TU (1)