The purpose of study is to determine the effect of two eye care methods (humid chamber, vitamin A eye ointment) in prevention from ocular surface disorders. Inclusion criteria: over 18 years old; corneal health in the initial of examination; hospitalized in intensive care unit at least for three days; conscious degree less than 8 according to Glasgow Coma Scale; inexistence of face or eye trauma; inexistence of eye problems history. Exclusion criteria: Existence of chemosis; eye lid position grade difference in the initial of examination; Bell’s palsy or hemiplegia; also if patient is capable of blinking for three days; corneal disorder at any stage of the test, recorded and the patient excluded from study continuing. The society of under study: our sample include of patients hospitalized in intensive care unit of Tabriz Alinasab Hospital. Sample size: First, a small sample of 15 patients selected and then sample size is determined. Intervention require: before each time of intervention, the standard eye care which means irrigation of eye and its surrounding skin with normal saline is done. Each of the eyes of patient randomized will receive one of the eye cares for five days. Thus about two centimeters vitamin A eye ointment is applied on inferior fornix in one eye every 6 hour and the other eye will cover with polyethylene cover. The cover will change every 12 hours. Patients are examined daily for the presence of corneal ulcer, dry eye assess with Schirmer test before and end of time the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201402116318N3
Registration date:2014-03-19, 1392/12/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-03-19, 1392/12/28
Registrant information
Name
Monir Nobahar
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4190
Email address
Nobahar43@Yahoo.com
Recruitment status
Recruitment complete
Funding source
University of Medical Sciences
Expected recruitment start date
2014-02-21, 1392/12/02
Expected recruitment end date
2014-07-24, 1393/05/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of ophthalmic vitamin A ointment and moisture chamber to prevent ocular surface disorders in critically ill patients
Public title
Comparing the effectiveness of ophthalmic vitamin A ointment and moisture chamber to prevent ocular surface disorders in critically ill patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: over 18 years old; corneal health in the initial of examination; hospitalized in intensive care unit at least for three days; conscious degree less than 8 according to Glasgow Coma Scale; inexistence of face or eye trauma; inexistence of eye problems history. Exclusion criteria: Existence of chemosis, eye lid position grade difference in the initial of examination; Bell’s palsy or hemiplegia; also if patient is capable of blinking for three days; corneal disorder at any stage of the test, recorded and the patient excluded from study continuing.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
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
Semnan University of Medical Sciences
Street address
Semnan, University of Medical Sciences, Nursing and Paramedical University
City
Semnan
Postal code
3513138111
Approval date
2014-03-04, 1392/12/13
Ethics committee reference number
92/415407
Health conditions studied
1
Description of health condition studied
Ocular Surface disorders
ICD-10 code
H16.8
ICD-10 code description
Other keratitis
Primary outcomes
1
Description
Ocular surface disorders
Timepoint
In 1th to 5th days
Method of measurement
The assessment tool of ocular surface disorders in this study is including Schirmer and Fluorescein tests. Schirmer test is done one time before the initiation and one time at the end of the study. To do the test Schirmer's graded paper will inserted in inferior fornix of lower eyelid at the junction of the middle third and outer third of the eyelid and the eyelid is closed and after five minutes, the height of the paper moist is measured in millimeters. Fluorescein test done daily till five days. Thus after corneal staining with fluorescein, existence of corneal damage assess by using pen light with blue light (cobalt) and 20 diopter lens and the test result is ranking according to Oxford grading scale.
Secondary outcomes
empty
Intervention groups
1
Description
After standard eye care (washing the eye and the skin around the eye with five to 10 cc saline), one of the patient' eye were randomized receives a piece of thin layer of transparent polyethylene to cover the eye from the eyebrow to the cheek bone every 12 hour. Anti-allergy adhesive tape was used to secure the edges of the polyethylene cover.
Category
Other
2
Description
After standard eye care (washing the eyelids and the skin around the eye with five to 10 cc saline), one of the patient' eye were randomized, every 6 hour, about two centimeters the vitamin A ophthalmic ointment are apply into the inferior fornix by the patient' nurse and the eyelid is closed by hand.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Alinasab Hospital
Full name of responsible person
Monir Nobahar
Street address
Semnan, University of Medical Sciences, Nursing and Paramedical University
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr.Raheb Ghorbani
Street address
Semnan, Bolvar Basij, University of Medical Sciences
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Dr. Monir Nobahar
Position
Dr
Other areas of specialty/work
Street address
Semnan, University of Medical Sciences, Nursing and Paramedical University
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4170
Fax
+98 23 1335 4161
Email
Nobahar43@sem-ums.ac.ir Nobahar43@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Monir Nobahar
Position
Dr
Other areas of specialty/work
Street address
Semnan, University of Medical Sciences, Nursing and Paramedical University
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4170
Fax
+98 23 1335 4161
Email
Nobahar43@sem-ums.ac.irNobahar43@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Monir Nobahar
Position
Dr
Other areas of specialty/work
Street address
Semnan, University of Medical Sciences, Nursing and Paramedical University
City
Semnan
Postal code
3513138111
Phone
+98 23 1335 4170
Fax
+98 23 1335 4161
Email
Nobahar43@sem-ums.ac.irNobahar43@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)