Comparing the effect of vitamin A ointment and Liposic gel for prevention of corneal abrasion during general anesthesia in nonocular surgeries
Design
parallel group blinded randomized trial on 50 patients
Settings and conduct
Sampling is performed in the operating room of hospitals affiliated to Arak University of Medical Sciences. Intervention group 1 (Vitamin A ointment) and intervention 2(Liposic gel) are assigned. As soon as the study was completed, demographic information is recorded . The eyes are examined for corneal damage before anesthesia, immediately after anesthesia, and 24 hours later. All assessments are performed by a researcher trained by an ophthalmologist who is unaware of the classification. Fluorescein paper and a flashlight with a cobalt blue light filter are used to assess corneal damage. 24 hours after surgery patient's eye discomfort questionnaire by patient is completed. patient is unaware of the assignment of groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients older than 18 years and less than 75 years; Patients undergoing non-ocular surgery with general anesthesia; No obvious damage to face and eyes; Lack of recent hospitalization in intensive care unit; No eye diseases (keratitis, keratopathy, glaucoma and other eye diseases); American Society Of Anesthesiologist Physical status I and II; Duration of surgery between 60-300 minutes; Supine position during surgery
Exclusion criteria:
Head and neck surgery; Need for invasive interventions and hospitalization in intensive care units; End of surgery before 60 minutes
Intervention groups
As soon as anesthesia and blinking reflex disappear in the first group eye care is given with vitamin A and in second group eye care is given with Liposic eye gel
Main outcome variables
Corneal abrasion
Ophthalmic discomfort
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180107038251N4
Registration date:2020-10-14, 1399/07/23
Registration timing:prospective
Last update:2020-10-14, 1399/07/23
Update count:0
Registration date
2020-10-14, 1399/07/23
Registrant information
Name
Nazanin Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3366 1308
Email address
nazaninamini69@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of vitamin A ointment and Liposic gel for prevention of corneal abrasion during general anesthesia in nonocular surgeries
Public title
Comparing the effect of vitamin A ointment and Liposic gel for prevention of corneal abrasion
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients older than 18 years and less than 75 years
Patients undergoing non-ocular surgery with general anesthesia
No obvious damage to face and eyes
Lack of recent hospitalization in intensive care unit
No eye damage before surgery according to the patient
No eye diseases (keratitis, keratopathy, glaucoma and other eye diseases)
American Society Of Anesthesiologist Physical status I and II
Patients with endotracheal intubation
Duration of surgery between 60-300 minutes
Supine position during surgery
No allergy to fluorescein
No pregnancy
Negative preoperative fluorescein staining
No severe systemic diseases
Do not use drugs that affect the production of tears in a recent month
Exclusion criteria:
Head and neck surgery
Death during surgery
Lack of patient cooperation and inability to answer questions related to ocular symptoms after surgery
Need for invasive interventions and hospitalization in intensive care units
End of surgery before 60 minutes
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Patient's two eyes are divided into two groups of intervention 1 and intervention 2 using simple random sampling method. 25 envelopes containing the letters A (right eye of vitamin A ointment and left eye of Liposic gel) and envelopes containing the letters B (right eye of Liposic gel and left eye of vitamin A ointment) are prepared. With this method, the right eye of half of patients is placed in the group of vitamin A ointment and the right eye of half of the patients is placed in the group of Liposic gel and vice versa.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients and examiners are not aware of the allocation of groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Railroad Street, Alamol Huda Street
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2020-10-03, 1399/07/12
Ethics committee reference number
IR.arakmu.REC.1399.208
Health conditions studied
1
Description of health condition studied
Corneal abrasion
ICD-10 code
S05.0
ICD-10 code description
Injury of conjunctiva and corneal abrasion without foreign body
Primary outcomes
1
Description
Corneal abrasion
Timepoint
Immediately after anesthesia, when leaving the recovery room, 24 hours after surgery
Method of measurement
Fluorescein paper and a flashlight with a cobalt blue light filter are used to assess corneal abrasion.
Secondary outcomes
1
Description
Ophthalmic discomfort
Timepoint
24 hours after surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group1: As soon as anesthesia and blinking reflex disappears, in the first group, eye care is given with vitamin A so that the researcher first washes his hands and wears clean gloves, then his thumb near the lower eyelid. Apply a gentle pressure to the cheekbones and lower the eyelid to fully expose the conjunctival sac. Then apply vitamin A ointment to the patient's eye without contact with the eyelid or eyelashes and place in the bag. The conjunctiva is placed 1 cm long so that it covers the surface of the eye and then closes the patient's eye with the hand.
Category
Prevention
2
Description
Intervention group 2: As soon as anesthesia and blinking reflex disappears, in the second group, eye care is given with Liposic gel so that the researcher first washes his hands and wears clean gloves, then his thumb near the lower eyelid. Apply a gentle pressure to the cheekbones and lower the eyelid to fully expose the conjunctival sac. Then apply Liposic gel to the patient's eye without contact with the eyelid or eyelashes and place in the bag. The conjunctiva is placed 1 cm long so that it covers the surface of the eye and then closes the patient's eye with the hand
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak Valiasr education and treatment center
Full name of responsible person
Nazanin Amini
Street address
Valiasr education and treatment center, Valiasr square
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3507
Email
nazaninamini69@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Korosh Rezaei
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3506
Email
rezaeikorosh0@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Nazanin Amini
Position
MSc nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Paramedicine, Arak University of Medical Sciences, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3507
Email
nazaninamini69@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Korosh Rezaei
Position
MSc in Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3507
Email
k.rezaei@arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nazanin Amini
Position
MSc in nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Paramedicine, Arak University of Medical Sciences, Sardasht
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3417 3507
Email
nazaninamini69@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available