Comparison of the effect of 40% autologous serum drop with artificial tear drop in improving corneal epithelial injury after corneal collagen cross-linking surgery, epithelium-off: a double-blind randomized controlled trial).
main objective: Comparison of the effect of 40% autologous serum drop with an artificial tear drop in improving corneal epithelial injury after corneal collagen cross-linking surgery, epithelium-off
Design
Using computer software (Random Allocation Software), the study subjects are placed into two intervention groups through blocks of four and six with an allocation ratio of 1:1 in two groups.
The random allocation sequence will be generated by a person not involved in the research. The drops will be numbered according to the generated sequence from 1 to 34.
Settings and conduct
In this double-blind randomized controlled trial, patients with keratoconus will be included in the study and will be randomly divided into two intervention groups (40% autologous serum drop) and control group (artificial tear drop). First, one eye of the patients will be operated. Then the second eye will also operated and then the patients will be followed up for 2 weeks. Autologous serum drop every two hours along with a topical antibiotic every 6 hours will be used by the patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Patients with bilateral keratoconus ready for surgery, none of whose eyes have been cross-linked before.
2- Consent to participate in the study
Exclusion criteria:
Patients with corneal thickness less than 400 microns, history of ocular herpes, recent history of any type of eye infection, presence of corneal scarring or opacity, neurotrophic keratopathy, positive history of autoimmune diseases and pregnancy
Intervention groups
intervention group (40% autologous serum drop) and control group (artificial tear drop).
Main outcome variables
pain intensity; Epithelium closure time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161218031450N6
Registration date:2023-10-29, 1402/08/07
Registration timing:retrospective
Last update:2023-10-29, 1402/08/07
Update count:0
Registration date
2023-10-29, 1402/08/07
Registrant information
Name
Ali Mostafaie
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3655 1332
Email address
mostafaeia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-09, 1402/06/18
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
2023-09-06, 1402/06/15
Actual recruitment end date
2023-10-23, 1402/08/01
Trial completion date
2023-10-23, 1402/08/01
Scientific title
Comparison of the effect of 40% autologous serum drop with artificial tear drop in improving corneal epithelial injury after corneal collagen cross-linking surgery, epithelium-off: a double-blind randomized controlled trial).
Public title
Comparison of the effect of 40% autologous serum drop with artificial tear drop in improving corneal epithelial injury after corneal collagen cross-linking surgery,
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with bilateral keratoconus ready for surgery, none of whose eyes have been cross-linked before.
Consent to participate in the study
Patients with keratoconus in both eyes
Exclusion criteria:
Patients with a corneal thickness less than 400 microns
history of ocular herpes
recent history of any type of eye infection
presence of corneal scarring or opacity
neurotrophic keratopathy
positive history of autoimmune diseases
Pregnancy
Age
From 18 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
34
Actual sample size reached:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Using computer software (Random Allocation Software), the study subjects are placed into two intervention groups through blocks of four and six with an allocation ratio of 1:1 in two intervention groups (40% autologous serum) or control (artificial tear drops). The random allocation sequence will be generated by a person not involved in the research. The drops will be numbered according to the generated sequence from 1 to 34. The first drop will be given to the first patient who is eligible for the study and this will continue until the samples are completed. How to use eye drops will be taught
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients will be divided into two groups based on the randomization form. The patients and outcome assessor will not know how the drug was used. The data analyzer will also be unaware of how the drug is used in both groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
tabriz university of medical science
Street address
abbasi street, nikookari eye hospital
City
tabriz
Province
East Azarbaijan
Postal code
4514436452
Approval date
2023-09-04, 1402/06/13
Ethics committee reference number
IR.TBZMED.REC.1402.436
Health conditions studied
1
Description of health condition studied
Keratoconus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
corneal epithelium closure
Timepoint
1,2,3 post op days.
Method of measurement
with slit lamp
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
nikookari eye hospital
Full name of responsible person
sajjad soltani
Street address
abbasi
City
tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 5609
Email
s.soltani030@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
محمد سمیعی
Street address
abbasi
City
tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 7330
Email
nikohosp@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Mostafaei
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Abbasi St. Nikoocari Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 7330
Email
alimostafaie@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Mostafaei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Abbasi St. Nikoocari Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 7330
Email
alimostafaie@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
sajjad soltani
Position
resident
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Abbasi St. Nikoocari Hospital
City
TABRIZ
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 7330
Email
s.soltani030@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