Effect of polyethylene film and artificial tear versus normal saline on the incidence of superficial ocular disorders in unconscious patients: a triple blind randomized clinical trial
Objectives: To assess the effect of polyethylene film and artificial tear versus normal saline on the incidence of superficial ocular disorders in unconscious patients.
Design: a triple blind randomized clinical trial.
Setting and conduct: The eligible unconscious patients who are hospitalized in ICU ward of Besat Hospital will be enrolled into the trial.
Inclusion criteria: age of 18 to 80 years; conscious level of 8 or lower based on GCS scale; healthy cornea; lack of blinking reflex.
Exclusion criteria: head trauma; history of cataract surgery; history of glaucoma; increasing the conscious level above 8 based on GCS scale; backing the blinking reflex; need to cardiopulmonary resuscitation.
Intervention group 1: Covering the eye with polyethylene film and replacing it every 12 hours for 5 days.
Intervention group 2: Dropping 2 drops of artificial tear every 6 hours for 5 days.
Control group: Irrigation of eye with normal saline every 6 hours for 5 days.
Primary outcome: Assessing the superficial ocular disorders on first and fifth days through physical examination.
Secondary outcome: Nothing.
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201609129014N115
Registration date:2016-09-21, 1395/06/31
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-21, 1395/06/31
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-10-01, 1395/07/10
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of polyethylene film and artificial tear versus normal saline on the incidence of superficial ocular disorders in unconscious patients: a triple blind randomized clinical trial
Public title
Effect of polyethylene film and artificial tear versus normal saline on the incidence of superficial ocular disorders in unconscious patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 to 80 years; conscious level of 8 or lower based on GCS scale; healthy cornea; lack of blinking reflex.
Exclusion criteria: head trauma; history of cataract surgery; history of glaucoma; increasing the conscious level above 8 based on GCS scale; backing the blinking reflex; need to cardiopulmonary resuscitation.
Age
From 18 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups using block randomization.
Blinding: Patients will be unaware of the type of intervention. The physician who will examine the patients will not be aware of the intervention. The analyzer will be unaware of the type of interventions. Therefore, the trial will be run as triple blind.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-08-27, 1395/06/06
Ethics committee reference number
IR.UMSHA.REC.1395.262
Health conditions studied
1
Description of health condition studied
unconscious patients
ICD-10 code
R40.2
ICD-10 code description
Coma, unspecified
Primary outcomes
1
Description
Assessing the superficial ocular disorders
Timepoint
on the first and fifth days
Method of measurement
through physical examination
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Covering the eye with polyethylene film and replacing it every 12 hours for 5 days
Category
Prevention
2
Description
Dropping 2 drops of artificial tear every 6 hours for 5 days
Category
Prevention
3
Description
Irrigation of eye with normal saline every 6 hours for 5 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Hamid Moradi Amin
Street address
Besat Hospital, Shahed Square
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan 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
Besat Hospital
Full name of responsible person
Hamid Moradi Amin
Position
Nursing Student
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
hamidma888@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Besat Hospital
Full name of responsible person
Hamid Moradi Amin
Position
Nursing Student
Other areas of specialty/work
Street address
Besat Hospital, Shahed Square
City
Hamadan
Postal code
Phone
+98 81 3364 0030
Fax
Email
hamidma888@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)