Aim of Study: In this study, we will compare the effect of Vitamin A and simple eye ointment based on Paraffin in patients undergoing general anesthesia for non-ophthalmic surgery .
Study design: Randomized, double-blind, controlled with a single eye ointment to both eyes, single-center.
Inclusion criteria: All patients undergoing general anesthesia for non-ophthalmic surgery are being studied.
Exclusion criteria: Patients who have a history of ocular surgery; Patients who wear eye contact lenses; Patients who have visual acuity of less than 20/100; patients who have a history of ocular disease; Patients who are allergic to adhesive tape or have a history of eye ointment; Pregnant Women; Patients with conjunctivitis; ocular prosthesis; ocular hypoperfusion secondary to hypotension or anemia or using a beta blocker and a diuretic such as hydrochlorothiazide due to decrease in tear production base are excluded.
Sample size: 130
Intervention Study: The only two common ways of medical treatment will compare.
Study outcome: To reduce ocular complications in patients undergoing general anesthesia for non-ophthalmic surgery by taking a more effective ointment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072418581N1
Registration date:2015-12-11, 1394/09/20
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-11, 1394/09/20
Registrant information
Name
Seyedeh Sara Bayesh
Name of organization / entity
Islamic Azad University, Tehran Medical Sciences Branch, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 912 671 1171
Email address
sarabayesh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Investigators
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-01-20, 1394/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ocular complications following the use of Vitamin A and simple eye topical ointment in non-ophthalmic surgery during general anesthesia
Public title
Ocular complications following the use of Vitamin A and simple eye ointment in non- ophthalmic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: In this study, all patients undergoing general anesthesia for non-ophthalmic surgery are being studied.
Exclusion criteria: Patients who have a history of ocular surgery; Patients who wear eye contact lenses; Patients who have visual acuity of less than 20/100; patients who have a history of ocular disease; Patients who are allergic to adhesive tape or eye ointment; Pregnant Women; Patients with conjunctivitis; ocular prosthesis; ocular hypoperfusion secondary to hypotension or anemia or using a beta blocker and a diuretic such as hydrochlorothiazide due to decrease in tear production base are excluded.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using the random blocks
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Islamic Azad University of Medical Sciences Branch
Street address
Tehran Medical Sciences Branch, Islamic Azad University, Khaghani St, Shariati Ave
City
Tehran
Postal code
19395/1495
Approval date
2014-11-15, 1393/08/24
Ethics committee reference number
93/8-1033
Health conditions studied
1
Description of health condition studied
Eye pain, Blurry vision, Tearing, Red eye, Photophobia, Foreign body sensation, Allergic reactions, Periorbital edema, Itchy, Sticking of the eyes together, Conjunctiva hyperemia, Scleral erythema, Corneal erosions
ICD-10 code
H59.9
ICD-10 code description
Postprocedural disorder of eye and adnexa, unspecified
Primary outcomes
1
Description
Any type of eye complications as eye pain, Blurry vision, Tearing, Red eye, Photophobia, Foreign body sensation, Allergic reactions, Periorbital edema, Itchy, sticking of the eyes together, Conjunctiva hyperemia, Scleral erythema, Corneal erosions
Timepoint
3to5 hours after general anesthesia, within the 24 hours after anesthesia, after discharge, more investigating in case of any complications
Method of measurement
Visual Analog Scale(VAS), Snellen Eye Chart, Schirmer's test,Scoring system for periorbital oedema, Oxford Schema
Secondary outcomes
1
Description
-
Timepoint
3to5 hours after general anesthesia, within the 24 hours after anesthesia, after discharge, more investigating in case of any complications
Method of measurement
Visual Analog Scale(VAS), Snellen Eye Chart, Schirmer's test, Scoring system for periorbital oedema, Oxford Schema
Intervention groups
1
Description
Intervention group1: (Two standards common types of eye ointments simultaneously into one patient's eye during general anesthesia). Vitamin A ointment (Xerovit, containing 250 units per gram of vitamin A palmitate at the base of Vaseline) without tape into one eye and simple eye ointment(Lubratex, Yellow Soft Paraffin 80 g, Wool Fat 10 g, Liquid Paraffin QS to 100 g) without tape is applied into another eye of patients (A thin layer of ointment approximately one centimeter is placed inside the lower eyelid during anesthesia).
Category
Prevention
2
Description
Intervention group 2: (one type of common standard eye ointment into both patient's eye during general anesthesia). Vitamin A ointment is applied into both eyes of patients and simple eye ointment into both eyes of patients (A thin layer of ointment approximately one centimeter is placed inside the lower eyelid during anesthesia).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Boo-Ali Hospital
Full name of responsible person
Dr Farshid Gholami/Anesthesiologist/Assistant professor/Member of science committee in Islamic Azad
Street address
Boo- Ali Hospital, Damavand St, Emam Hossein Sq
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Azad University of Medical Sciences
Full name of responsible person
Dr Hassan Eftekharardebili
Street address
Tehran Medical Sciences Branch, Islamic Azad University, Khaghani St, Shariati Ave
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Azad 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
Islamic Azad University, Tehran Medical Sciences Branch, Tehran, Iran
Full name of responsible person
Seyedehsara Bayesh
Position
Medical student
Other areas of specialty/work
Street address
Tehran Medical Sciences Branch, Islamic Azad University, Khaghani St, Shariati Ave
City
Tehran
Postal code
19395/1495
Phone
+98 912 124 2941
Fax
Email
sarabayesh@yahoo.com; frgholami@gmail.com
Web page address
www.iautmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University, Tehran Medical Sciences Branch, Tehran, Iran
Full name of responsible person
Dr Farshid Gholami
Position
Anesthesiologist, Assistant professor, Member of science committee
Other areas of specialty/work
Street address
Tehran Medical Sciences Branch, Islamic Azad UniversityT, khaghani St, shariati Ave