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A comparative survey of three methods eye care using polyethylene cover, polyethylene cover and eye drop and polyethylene cover and eye ointment, to prevent dry eye and corneal abrasion in ICU patients

Protocol summary

Summary
The aim of study is comparing the effectiveness of three methods of eye care including polyethylene cover, polyethylene cover and eye drop, and polyethylene cover and ointment, in the prevention of dry eye and corneal abrasions in hospitalized patients in Intensive Care Unit at teaching Hospitals of Ilam. In this randomized controlled single blind study the samples consist of 172 patients. Inclusion criteria include absence of dryness and corneal abrasion, being connected to the ventilator and incomplete closure of the eyelids. Exclusion criteria are returning of blinking reflex and extubation. Patients will be randomly assign to one of the three groups including polyethylene cover, cover and eye drop, and cover and eye ointment. In each patient, one eye receives routine interventions, and the other one will receive the intervention. In cover group, polyethylene cover is placed on the eye. In cover and drop group, in addition to covering, a drop is dropped in to the lower eyelid every 8 hours. In cover and ointment group, in addition to covering an ophthalmic ointment is used every 8 hours. Finally, after five days, the both eyes will be examine and compare for dryness and abrasion.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201506294736N8
Registration date: 2016-07-02, 1395/04/12
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-07-02, 1395/04/12
Registrant information
Name
Alireza Khatony
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3827 9394
Email address
akhatony@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative survey of three methods eye care using polyethylene cover, polyethylene cover and eye drop and polyethylene cover and eye ointment, to prevent dry eye and corneal abrasion in ICU patients
Public title
Evaluation of three methods of eye care in the prevention of ocular surface diseases
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age over 18 years, GCS ≤ 8, the absence of trauma to the head and face, the lack of a history of eye disease, absence of eye problems caused by diabetes, no history of hospitalization in the ICU over the past month, tracheal tube, connected to mechanical ventilation, length of stay more than 24 hours in the ICU, closing eyelids partially due to the use of neuromuscular relaxants, the negative result of Schirmer and fluorescein test. Exclusion criteria: Return of blinking reflex, extubation, the death of patient, patient transfer  to ward
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 172
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Blv, Kermanshah University of Medical Sciences, Kermanshah, Iran
City
Kermanshah
Postal code
Approval date
2016-06-08, 1395/03/19
Ethics committee reference number
177

2

Ethics committee
Name of ethics committee
kermanshah university of medical science
Street address
kermanshah, Azadi square, beheshti blvar
City
kermanshah
Postal code
Approval date
2016-06-08, 1395/03/19
Ethics committee reference number
177

Health conditions studied

1

Description of health condition studied
corneal erosion
ICD-10 code
H 16.0
ICD-10 code description
corneal ulcer

2

Description of health condition studied
dry eye
ICD-10 code
H 04.1
ICD-10 code description
Dry eye syndrom

Primary outcomes

1

Description
dry eye, due to reduced blinking reflex
Timepoint
At the start of intervention and then daily during 5 days
Method of measurement
Schirmer Test

2

Description
Corneal abrasion caused by dry eye
Timepoint
At the start of intervention and then daily during 5 days
Method of measurement
manually slit lamp and fluorescein test

Secondary outcomes

empty

Intervention groups

1

Description
At the group A, a polyethylene coating is used on a daily basis for 5 days.
Category
Prevention

2

Description
In Group B, eye drop and polyethylene coating is used. One Drop is dropped inside of the eyelid every 8 hours. polyethylene coating is then put on the eye. Coverage will be replace on a daily basis or if worn or contaminated.
Category
Prevention

3

Description
In group C, polyethylene coating and ophthalmic ointment are used for 5 days. Ointment is used every 8 hours at a rate of 1 cm inside the lower eyelid. polyethylene coating replaced on a daily basis.
Category
Prevention

4

Description
In the control eye, routine cares such as using of antibiotic ointment, washing skin around the eye using tap water, and taping the eyelid will used.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Mostafa Khomeini Hospital
Full name of responsible person
Alireza Khatony
Street address
City
Ilam

2

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Alireza Khatony
Street address
City
Ilam

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Kermanshah University of Medical Sciences, Shahid Beheshty Blv, Kermanshah University of Medical Sciences, Kermanshah, Iran
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
Faculty Member , PhD in Nursing Education
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3827 9496
Fax
Email
akhatony@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
Faculty member, PhD in Nursing Education
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Postal code
Phone
+98 83 3827 9496
Fax
Email
akhatony@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah School of Nursing and Midwifery
Full name of responsible person
Alireza Khatony
Position
PhD in Nursing Education
Other areas of specialty/work
Street address
Nursing Department, Kermanshah School of Nursing and Midwifery, Ashayer Blv., Kermanshah, Iran
City
Kermanshah
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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