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

NCT ID: NCT05874453

Last Updated: 2025-03-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-15

Study Completion Date

2025-08-15

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.

Detailed Description

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Conditions

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Ocular Complications Eye Protocol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Group

Eye care protocol to be appliedevaluation.

Group Type EXPERIMENTAL

eye care protocol

Intervention Type 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

Control Group

Routine intensive care Eye care protocol to be applied

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Özlem Ceyhan

Assoc.Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Erciyes University Hospital

Kayseri, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Özlem Ceyhan, Assoc.Prof.

Role: CONTACT

+903522076666 ext. 28561

Facility Contacts

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Özlem Ceyhan, Assoc.Dr.

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 36319529 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18810388 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31394552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29353117 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20191796 (View on PubMed)

Other Identifiers

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EYEPROTOCHOL

Identifier Type: -

Identifier Source: org_study_id

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