The aim of the study is to compare the effect of ointment and tape on prevention of corneal abrasion and dryness in ICU patients in Kashan and Tehran selected hospitals. In this study 90 patients who all are hospitalized in Intensive Care Units for at least 5 days, with Glasgow Coma Scale less than 8 and no blinking response and no history of eye trauma and surgery will randomly allocate to 3 groups. All the patients in ointment and tape group will receive eye care including eye irrigation every 8 hours by a qualified nurse then the tape or ointment will be applied to the eyes. The third group will receive the routine care. The corneal dryness and defect will be studied in the first day of admission and 5 days later by an ophthalmologist. In the fifth day the occurance of corneal drynes and corneal ulcer as the oucome variable will be determined by an ophatlmologist and the groups will be compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104186228N1
Registration date:2011-08-20, 1390/05/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2011-08-20, 1390/05/29
Registrant information
Name
Negin Masoudi Alavi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
masudialavi_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Science
Expected recruitment start date
2011-08-21, 1390/05/30
Expected recruitment end date
2011-12-21, 1390/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of two types of eye care for prevention of corneal dryness and corneal defect in ICU patients
Public title
The prevention of eye problems in ICU patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Hospitalized in ICU for at least 5 days; Glasgow Coma Scale less than 8 in admission; No blinking response, normal shirmer test in admission; age between 20-65.
Exclusion criteria: History of diabetes; thyroid and liver diseases; history of eye surgery.
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Science
Street address
Faculty of Nursing and Midwifery, Kashan University of Medical Science, Ghotb Ravandi Highway, Kashan, Iran
City
Kashan
Postal code
Approval date
2011-07-26, 1390/05/04
Ethics committee reference number
1342/1/5/29/پ
Health conditions studied
1
Description of health condition studied
Corneal ulcer and dryness
ICD-10 code
H16.0
ICD-10 code description
Corneal ulcer
Primary outcomes
1
Description
Corneal ulcer
Timepoint
First day and fifth day
Method of measurement
Flourecent test
2
Description
Corneal dryness
Timepoint
First day and fifth day
Method of measurement
Shirmer test
Secondary outcomes
1
Description
none
Timepoint
none
Method of measurement
none
Intervention groups
1
Description
The patients will recieve the routine eye care in the ward
Category
Prevention
2
Description
Eye irrigation every 8 hours and applying adhesive tape horizentaly to close the eye by nurse.
Category
Prevention
3
Description
Eye irrigation every 8 hours and applying the lubricant eye ointment by nurse.