Effect of autologous serum drop on the occurrence of exposure keratopathy in patients hospitalized in intensive care units
Design
Non blinded parallel randomized clinical trials with control group
Settings and conduct
The present study is a clinical trial will be perform in the intensive care unit of Vali-e-Asr Hospital in Arak. Patients are selected using targeted sampling and are included in the study, and one of the eyes is cared by the "A" and the other by "B" methods.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Hospitalization in intensive care unit
16 - 65 years old
Signing the consent form
Awareness score less than 10 according to Glasgow Coma Scale
No history of eye disease before hospitalization
Non-traumatic face and eye
No history of consumption of ointment and ocular drops before hospitalization
Exclusion criteria:
Unwillingness to participating in the study
Intervention groups
One of the eyes is cared with "A" and the other with "B" methods. Coin throwing is done to determine the care method in each eye.
In other words, "A" care method is considered as a control group and the "B" care method as an intervention group.
"A" care method includes: Wash hands before eye care - Eye wash with sterile sterile technique, every 6 hours - use of artificial tear drops every six hours - covering the eye with the pad at the time of suction.
In the "B" care method, in addition to the above actions, two drops of autologous serum drops are used every six hours.
Main outcome variables
Exposure keratopathy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161210031328N9
Registration date:2019-04-10, 1398/01/21
Registration timing:retrospective
Last update:2019-04-10, 1398/01/21
Update count:0
Registration date
2019-04-10, 1398/01/21
Registrant information
Name
Mahbobeh Sajadi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3402 0115
Email address
m.sajadi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-12-11, 1397/09/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of autologous serum drop on the occurrence of exposure keratopathy in patients hospitalized intensive care units
Public title
The effect of autologous serum drops on keratopathy in patients hospitalized in intensive care unit
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Hospitalization in intensive care unit
16 - 65 years old
Signing the consent form
Awareness score less than 10 according to Glasgow Coma Scale
No history of eye disease before hospitalization
Non-traumatic face and eye
No history of consumption of ointment and ocular drops before hospitalization
Exclusion criteria:
Unwillingness to participating in the study
Age
From 16 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
One of the eyes is cared with "A" and the other with "B" care methods. Coin throwing is done to determine the care method in each eye. Therefore, in some patients, the left eye, and in some patients, the right eye is cared with the "B" method, and so the "A" care is done both in the right eye and in the left eye of the patients.
In other words, care "A" care method is considered as a control group and a "B" care method as an intervention 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 Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2019-01-21, 1397/11/01
Ethics committee reference number
IR.ARAKMU.REC.1397.291
Health conditions studied
1
Description of health condition studied
Keratopathy
ICD-10 code
H18.9
ICD-10 code description
Unspecified disorder of cornea
Primary outcomes
1
Description
Exposure keratopathy
Timepoint
Examination of the eye before study, using fluorescein paper and ophthalmoscope with blue cobalt light filter, and then daily and at the beginning of each day.
Method of measurement
The scale of corneal changes
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The right eye will be considered as intervention group. In addition to routine care, autologous serum drops are cast in the right eye every six hours. In order to provide an autologous serum, 10 to 20 ml of blood will be taken from the patient and according to the standard protocol in the laboratory of Valiasr Hospital in Arak, six sterile drops are prepared.
Category
Prevention
2
Description
Control group: The left eye of patients will be considered as control group. In this group, routine care will be done on the eye.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Vali-e-asr Hospital
Full name of responsible person
Seyed Mohammad Jamalian
Street address
Vali-e-asr Hospital, Vali-e-asr sq.
City
Arak
Province
Markazi
Postal code
3814957558
Phone
+98 86 3222 2003
Email
pr_valieasr@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohammad Arjomandzadegan
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
info@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
sajadimahbobeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sina Dehghan
Position
MSc. Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
sina.dehghan.acns@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Sina Dehghan
Position
MSc. Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences, Basij Sq., Sardasht Region
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3505
Email
sina.dehghan.acns@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Part of the data, such as information on the main outcome and the demographic information, can be shared.
When the data will become available and for how long
36 months after publishing of results.
To whom data/document is available
Researchers in academic and scientific institutions.
Under which criteria data/document could be used
In order to utilize scientific purposes and mention the source used.
From where data/document is obtainable
Dr. Mahboubeh Sajjadi
E-mail address: sajadimahbobeh@yahoo.com
What processes are involved for a request to access data/document
After receiving the email, the information will be sent within 2 to 3 working days.