Comparison of ocular lubratex and ocular vitamin A ointment in the prevention of ocular surface disorders (OSD) in Intensive Care Unit, A Randomized Clinical Trial
This study aimed to determine the efficacy of eye care (eye ointments Lubratex and topical vitamin A) in the prevention of ocular surface disorders. Inclusion criteria: Age over 18 years; the healthy cornea in the initial examination; admitted to the intensive care unit for at least for 5 days; consciousness score according to the Glasgow Coma Scale less than 10; lack of trauma to the face or eyes; no history of eye problems. Exclusion criteria: having chemosis; differences of scores in the preliminary examination of the eyelid position; Bell's palsy or unilateral hemiplegia; allergy to Lubratex; closed suction method; if the patient is able to blink; corneal disorder at any stage of the testing.
Study population: patients who admitted in the intensive care units of( Imam Hossein and Bahar hospitals) in Shahroud. Sample size: 71 patients
The required intervention: Before each intervention, standard eye care including eyes cleaning and the skin around it is done with normal saline. Each patient's eye randomly assigned to receive one eye care for five days. So that, every six hours about two inches of vitamin A ointment is used in the lower fornix and in the other eye Lubratex ointment is used. Patients on the first and fifth days are examined by using Schirmer's and fluorescin tests for corneal ulcer.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017040733278N1
Registration date:2017-07-25, 1396/05/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-25, 1396/05/03
Registrant information
Name
Mitra Badparva
Name of organization / entity
Shahroud University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
badparva@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahroud University of Medical Sciences
Expected recruitment start date
2017-06-10, 1396/03/20
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ocular lubratex and ocular vitamin A ointment in the prevention of ocular surface disorders (OSD) in Intensive Care Unit, A Randomized Clinical Trial
Public title
Effect of eye ointmet lubratex in the prevetion ocular surface disorders (OSD)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Age over 18 years; the healthy cornea in the initial examination; admitted to the intensive care unit for at least for 5 days; consciousness score according to the Glasgow Coma Scale less than 10; lack of trauma to the face or eyes; no history of eye problems. Exclusion criteria: having chemosis; differences of scores in the preliminary examination of the eyelid position; Bell's palsy or unilateral hemiplegia; allergy to Lubratex; closed suction method; if the patient is able to blink; corneal disorder at any stage of the testing.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
71
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
Shahroud- 7th Tir square
City
Shahroud
Postal code
3614773955
Approval date
2017-05-28, 1396/03/07
Ethics committee reference number
ir.shmu.rec.1396.18
Health conditions studied
1
Description of health condition studied
Ocular Surface Disorders
ICD-10 code
H19-H22
ICD-10 code description
Disorders of sclera, cornea, iris and ciliary body
Primary outcomes
1
Description
Ocular Surface Disorders
Timepoint
Before intervention- 5 days after the intervention.
Method of measurement
Assessment tools for ocular surface disorders in this study including the Schirmer's and fluorescin tests. Schirmer's test once before and once when the study is completed will be done. To perform this test graded Schirmer's paper is placed in choledosac at the junction of the middle third and outer third of the eyelid and the lid is closed. After five minutes, wet bar's height is measured in millimeters. Fluorescein test once at the beginning and once on the fifth day is done.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After a standard eye care (eye wash and skin around it with normal saline) one of the eyes of patients is randomly selected. Then about two inches Lubratex Ointment every six hours, 5 days, is placed in lower eye fornix by the charge nurse and eyelids will be closed by hand.Patients on the first and fifth days are examined by using Schirmer's and fluorescin tests for corneal ulcer.
Category
Prevention
2
Description
Control group: After a standard eye care (eye wash and skin around it with normal saline) other patient’s eye is selected. Then about two inches vitamin A Ointment every six hours, 5 days, is placed in lower eye fornix by the charge nurse and eyelids will be closed by hand. Patients on the first and fifth days are examined by using Schirmer's and fluorescin tests for corneal ulcer.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Dr Mohammad Veshagh (An ophthalmologist)
Street address
Imam' Street, Imam Hossein Square
City
Shahroud
2
Recruitment center
Name of recruitment center
Bahar Hospital
Full name of responsible person
Dr Mohammad Veshagh (Ophthalmologist)
Street address
22 Bahman' Street
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Department of Technology and Research of Shahroud University of Medical Sciences
Full name of responsible person
Dr:Mohammad Hassan emamian
Street address
University of Medical Sciences, 7th Tir square
City
Shahroud
Grant name
دانشگاه علوم پزشکی شاهرود
Grant code / Reference number
دانشگاه علوم پزشکی شاهروذ
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Department of Technology and Research of Shahroud 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
Shahroud University of Medical Sciences
Full name of responsible person
Mitra Badparva
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Shahroud University of Medical Sciences
City
Shahroud
Postal code
3655173993
Phone
+98 23 3239 5054
Fax
+98 23 3239 4800
Email
badparva@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences. Shahroud, Iran.
Full name of responsible person
Hossein ebrahimi
Position
PhD in Nursing
Other areas of specialty/work
Street address
7th Tir square
City
Shahroud
Postal code
3655173993
Phone
+98 23 3239 3811
Fax
Email
ebrahimi@shmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Mitra Badparva
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Imam street, Imam Hossein Hospital
City
Shahroud
Postal code
3655173993
Phone
+98 23 3234 0457
Fax
Email
badparva@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)