this study was to identify the effect of an eye care program on the number of eye injuries in hospitalized patients in intensive care units
Design
This research is a clinical trial, conducted on 70 ICU patients who were selected by convenient sampling by random number boxes and assigned study (n=35) and control(n=35) groups by random allocation.
Settings and conduct
This study is hospitalized patients in intensive care units.One group received routine eye care (control group) and the other (test group) received eye care program(cleaning the eye every 8 hours and using simple eye ointment in eye ,closing the eyelid with tape and putting a wet pad on the eyes
Participants/Inclusion and exclusion criteria
Inclusion criteria were patients over 18 years of age with over 24 h on ventilator and GCS of less than 7. In cases of patients death, discharge or transition from ICU, increase in level of consciousness the patient is excluded.
Intervention groups
In control group, routine care including cleaning patients’ eyelids with a normal saline gauze. In study group, eyes are cleaning by a normal saline gauze while eyes closed and were dressed by eye ointments used in the lower sack of patients’ eye. Then, patients’ eyes are fixing by anti allergic transparent tape and covered by a normal saline gauze completely. This care is administrated during each working shift for 7 days for two groups. The patients are assessing concerning corneal injury with fluorescent test once a day in both groups if the patient showed a sign of corneal injury (positive fluorescent test) within 7 days undergoing assessment, and he ordered counseling with an ophthalmologist not only to diagnose the eye injury and its type but also to start relevant treatment .
Main outcome variables
using an eye care program, while taking care of hospitalized patients in intensive care unit is recommended to be an effective method in the prevention of ocular surface disorder.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160101025787N1
Registration date:2017-12-30, 1396/10/09
Registration timing:retrospective
Last update:2017-12-30, 1396/10/09
Update count:0
Registration date
2017-12-30, 1396/10/09
Registrant information
Name
Fouziyeh Mokhtari
Name of organization / entity
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7540
Email address
f.mokhtari1391@yahoo.com
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences
Expected recruitment start date
2014-05-31, 1393/03/10
Expected recruitment end date
2014-10-23, 1393/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of the eye care protocol on ocular damage in patients hospitalized in intensive care unit
Public title
eye care program
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients over 18 years of age
over 24hrs on ventilator
GCS of less than 7(without consideration of T score)
lack of eye blinks reflex
disability of keeping eyes closed
no ocular injury in fluorescent test
no head traumas
Exclusion criteria:
patients death
discharge or transition from ICU
loss of patient’s family’s interest to stay in study
increase in level of consciousness or return of eye blinks reflex
Age
From 18 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Firstly, subjects are selected through convenient sampling, and then, assigned to study and control groups through random allocation and with help of random numbers and case numbers, given to the subjects . It was so that the first number , taken out of the box , defines the subject to be given to control, and the next, the one given to the study group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, hezar-jarib street, Isfahan .
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶-۷۳۴۶۱
Approval date
2014-05-25, 1393/03/04
Ethics committee reference number
393242
Health conditions studied
1
Description of health condition studied
Ocular Surface Disorder
ICD-10 code
H16.0
ICD-10 code description
Corneal ulcer
Primary outcomes
1
Description
eye disorder
Timepoint
Daily for seven sequential days
Method of measurement
With Fluorescent test
Secondary outcomes
empty
Intervention groups
1
Description
In study group, while the eye lids are closed and are cleaned with normal saline gauze, eye ointment (loubratex containing white paraffin, lanolin and liquid paraffin, made by Sina Daroo company) is dropped into the lower eye sack of the patients, and then, the eye lids are closed and fixed by two anti-allergic transparent adherent tapes ( horizontally laid on the lower and upper eye lids). Normal saline sterile gauze is laid on patients’ eyes so as to cover the eyes completely. Then, these procedures are repeated in each working shift by the researcher and the nurse. In each shift, the assessment of the return of the patients’ blinking reflex is done by the nurse or the researcher during the implementation of the care plan on their eyes.
Category
Prevention
2
Description
In control group, assessment of patients’ blinking reflex and GCS is implemented by a trained nurse and the researcher. Patients also receive routine eye care, administrated in the ward, including cleaning the patients’ eye lids with saline normal gauze.