Protocol summary

Study aim
Comparison of three methods of ophthalmology in prevention of keratitis in ICU patients
Design
Triple blind with parallel groups
Settings and conduct
Study population and characteristics of the study. Patients admitted to ICU wards with lower consciousness level of 8. Less than 8) There is no history of eye problems in the patient's history. Patients undergoing ophthalmic examinations with blue light ophthalmoscopy and fluorescein testing will also be included when entering the ward if the cornea is healthy and without any other eye problems, as well as examination and examination of the patient's condition by the study physician. The patient will be placed in one of the eye care groups by simple random method (throwing dice). Place of Study: Shahid Sadoughi Hospital of Yazd Intensive Care Unit
Participants/Inclusion and exclusion criteria
Patients hospitalized in intensive care units Exclusion: Patients whose fluorescein test is positive at admission. Patients with trauma or injury. Entry requirements: Patients with decreased consciousness below 8. Connect to the ventilator. Impaired blink reflex.
Intervention groups
The patient will be assigned to one of the eye care groups by simple random method (Roll of a die). In this case, the number (comparison of the eye ointment and the anti-allergic glue), ( the eye and artificial tears ), ( Comparison of Anti-Allergenic Tape and Artificial Tears) Each patient will receive two care modes such that one eye will receive simple eye ointment and the other one will receive anti-allergic glue, thereby confounding the effects. Each patient's eye will receive eye care for 6 hours and then receive simple eye care, including washing with distilled water and cotton.
Main outcome variables
ocular keratitis.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200204046370N1
Registration date: 2020-04-13, 1399/01/25
Registration timing: retrospective

Last update: 2020-04-13, 1399/01/25
Update count: 0
Registration date
2020-04-13, 1399/01/25
Registrant information
Name
Elham Fazljoo
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3235 8700
Email address
e.fazljoo@ssu.ac
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-21, 1397/03/31
Expected recruitment end date
2019-02-28, 1397/12/09
Actual recruitment start date
2018-06-21, 1397/03/31
Actual recruitment end date
2019-02-28, 1397/12/09
Trial completion date
2019-05-20, 1398/02/30
Scientific title
Comparing the Effectiveness of Three Methods of eye care in the prevention of keratitis disorders In patients (ICU)
Public title
Comparing the Effectiveness of Three Methods of eye care in the prevention of keratitis disorders In patients (ICU)
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with decreased consciousness below 8. Connect the ventilator Impaired blink reflex Age over 18 years
Exclusion criteria:
Patients with eye damage at admission Patients who have had a history of diabetes and hypertension Patients whose fluorescein test is positive at admission Patients with trauma or injury.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
More than 1 sample in each individual
Number of samples in each individual: 2
Different eye care in each patient's eye
Actual sample size reached: 60
More than 1 sample in each individual
Actual sample size in each individual: 2
Different eye care in each patient's eye
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is used.Roll OF a die was used. So that the numbers 1 and 4 methods of eye ointment and anti-allergic adhesive, Numbers 2 and 5 Ophthalmic ointment and anti-allergic adhesive, Numbers 3 and 6 had anti-allergic adhesive and artificial tears. The randomization unit has also been individualized. Initially, any patient that entered the special ward ,examined by a specialist ICU physician and Inclusion and exclusion criteria were evaluated. If the patient met the inclusion criteria The patient was assigned to one of the treatment groups byrol of a die By a researcher . Then the eye care was done by another researcher and an eye examination was performed by an ophthalmologist.In order to conceal the throwing of the dice, it was done by the secretary who did not know the type of treatment in the groups, so that when the disease was accepted and approved by a special care specialist to attend the study, the secretary who was not part of the research team Throwing a dice determined which group the patient was in and informed the researcher It didn't happen random layers and random sequences.
Blinding (investigator's opinion)
Triple blinded
Blinding description
The subjects in this study were comatose patients. So they were not aware of their eye care. The person doing the eye care was a researcher .But the eye examination was done by an ophthalmologist who was not aware of the type of eye care. In this way, before the start of the eye examination, the type of care was cleared from the patient's eye. And the one who did the data analysis It only had group numbers And the type of care provided in each group was not known.
Placebo
Not used
Assignment
Parallel
Other design features
Nothing

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Yazd of Medical Sciences
Street address
No. 5, Fifth Alley, Shahd Zinly Alley, Fajr Dahi Boulevard
City
Yazd
Province
Yazd
Postal code
8914946819
Approval date
2017-01-10, 1395/10/21
Ethics committee reference number
IR.SSU.REC.1395.207

Health conditions studied

1

Description of health condition studied
Keratitis
ICD-10 code
H16.0
ICD-10 code description
Corneal ulcer

Primary outcomes

1

Description
Ocular keratitis
Timepoint
At the beginning of the study and on the seventh day
Method of measurement
Fluorescein Test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Ointment and anti-allergenic adhesive. Ointment care :Every 6 hours by a trained nurse investigator in one of the patient's eyes about 2 cm of ointment in the inferior fornix from the inside out with the sterilization technique, so that about 1 cm of the ointment is poured out at the beginning of the ointment and Avoid contact with the patient's eye ointment and have the nurse thoroughly wash their hands as well as any ointment specific to the patient. After pouring the ointment, the patient's eyes are gently closed and checked every two hours by the nurse for the eyelid to be closed. Every 6 hours the patient's eyes are washed by the nurse with sterile water and cotton. Care with anti-allergic adhesive (1 / 25cm wide)Every 6 hours, the eyelid is closed with an anti-allergic adhesive with a width of 1.27. In such a way that one piece of adhesive is placed horizontally on the upper eyelid and the other piece is placed vertically on the patient's eyelid so that it rests on the patient's cheek and eyelid. Examines in terms of damage. If the adhesive needs to be renewed, this will be done. Every 6 hours the patient's eyes will be rinsed with sterile water and cotton and the eye care will be re-applied.Eye care was performed 3 times every 24 hours. Eye care was performed at night.Consumption of sterile plain eye ointment 3.5 g (Lubratex): (lanolin content 10%, white platelet 80% and mineral oil 10%).CompanySina Daroo Tehran.Anti-allergic adhesive with width: 1/27.Company Sins Max
Category
Prevention

2

Description
Intervention group: Intervention group 1: Ointment and artificial tear. Ointment care :Every 6 hours by a trained nurse investigator in one of the patient's eyes about 2 cm of ointment in the inferior fornix from the inside out with the sterilization technique, so that about 1 cm of the ointment is poured out at the beginning of the ointment and Avoid contact with the patient's eye ointment and have the nurse thoroughly wash their hands as well as any ointment specific to the patient. After pouring the ointment, the patient's eyes are gently closed and checked every two hours by the nurse for the eyelid to be closed. Every 6 hours the patient's eyes are washed by the nurse with sterile water and cotton.Another patient's eye care was performed with artificial tears. That is, every 6 hours the nurse in charge trained by the researcher washes her hands and pours artificial tears into the other eye. For further care of the patient's eyes, the nurse is rinsed with sterile water and cotton, and the procedure is repeated again..Eye care was performed 3 times every 24 hours. Eye care was performed at night.Consumption of sterile plain eye ointment 3.5 g (Lubratex): (lanolin content 10%, white platelet 80% and mineral oil 10%).CompanySina Daroo Tehran.Sina Darou Tehran Artificial Tears
Category
Prevention

3

Description
Intervention group:anti-allergenic adhesive and artificial tear. Care with anti-allergic adhesive (1 / 25cm wide)Every 6 hours, the eyelid is closed with an anti-allergic adhesive with a width of 1.27. In such a way that one piece of adhesive is placed horizontally on the upper eyelid and the other piece is placed vertically on the patient's eyelid so that it rests on the patient's cheek and eyelid. Examines in terms of damage. If the adhesive needs to be renewed, this will be done. Every 6 hours the patient's eyes will be rinsed with sterile water and cotton and the eye care will be re-applie..Another patient's eye care was performed with artificial tears. That is, every 6 hours the nurse in charge trained by the researcher washes her hands and pours artificial tears into the other eye. For further care of the patient's eyes, the nurse is rinsed with sterile water and cotton, and the procedure is repeated again..Eye care was performed 3 times every 24 hours. Eye care was performed at night.Consumption of.Anti-allergic adhesive with width: 1/27.Company Sins Max and .Sina Darou Tehran Artificial Tears.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital of Yazd
Full name of responsible person
Elham Fazljoo
Street address
No. 33, Fifth Lane, Shahid Zineli Alley, Fajr Dahi Boulevard
City
Yazd
Province
Yazd
Postal code
894946819
Phone
+98 35 3624 6804
Fax
+98 35 3235 8700
Email
efazljoo@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
DR. Masood Mirzai
Street address
No. 33, Fifth Lane, Shahid Zineli Alley, Fajr Dahi Boulevard
City
یزد
Province
Yazd
Postal code
8914946819
Phone
+98 35 3624 6804
Fax
+98 35 3235 8700
Email
Efazljoo@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Elham Fazljoo
Position
Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 5, Fifth Alley, Shahd Zinly Alley, Fajr Dahi Boulevard
City
Yazd
Province
Yazd
Postal code
8914946819
Phone
+98 35 3624 6804
Fax
+98 35 3235 8700
Email
ٍEfazljoo@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
ٍElham Fazljoo
Position
Faculty memberیز
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 5, Fifth Alley, Shahd Zinly Alley, Fajr Dahi Boulevard
City
Yazd
Province
Yazd
Postal code
8914946819
Phone
+98 35 3624 6804
Fax
+98 35 3235 8700
Email
Efazljoo@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Elham Fazljoo
Position
Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
No. 5, Fifth Alley, Shahd Zinly Alley, Fajr Dahi Boulevard
City
Yazd
Province
Yazd
Postal code
8914946819
Phone
+98 35 3624 6804
Fax
+98 35 3235 8700
Email
Efazljoo@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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be published
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Specialists affiliated with medical universities
Under which criteria data/document could be used
Nurses working in the intensive care unit
From where data/document is obtainable
Efazljoo@gmail.com
What processes are involved for a request to access data/document
Necessary information on the cause of the need for data information Documentation needed for data
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