Comparison of the effect of Betamethasone vs. Lotemax vs. Floucort in post PRK IOP; measuring the effect of IOP on residual myopia; effect of Myopia on different refractive groups; the time needed to have normal IOP after cessation of drop
Design
Parallel group, single blind, randomised controlled trial
Settings and conduct
Simple randomization; optometrists and examiners and data analyzer are blind to the type of drop.
Participants/Inclusion and exclusion criteria
Patients referring to Farabi eye hospital refractive surgery clinic; myopia less than 6 and PRK candidate
Intervention groups
PRK candidates will be randomely devided into 3 groups. Each group get either betamethasone floucort or lotemax. The IOP will be checked after one month.
Main outcome variables
UDVA; CDVA; Sphere; Cylinder; IOP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190207042650N1
Registration date:2019-03-03, 1397/12/12
Registration timing:prospective
Last update:2019-03-03, 1397/12/12
Update count:0
Registration date
2019-03-03, 1397/12/12
Registrant information
Name
Hesam Hashemian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4473 7065
Email address
h_hashemian@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of betamethasone vs. Lotemax vs. Floucort in post PRK IOP
Public title
Comparison of different steroids in post PRK IOP
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Myopia<6
PRK candidate
Exclusion criteria:
Unwilling to accept the concept.
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
240
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Optometrists and examiners and data analysor are blind to the type of drop.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Research Ethics Committee Farabi Eye Hospital,Tehran University of Medical Sciences
Street address
Farabi Eye Hospital, Qhazvin sq.
City
Tehran
Province
Tehran
Postal code
133661616351
Approval date
2018-05-12, 1397/02/22
Ethics committee reference number
IR.TUMS.FARABIH.REC.1397 .004
Health conditions studied
1
Description of health condition studied
PRK candidate
ICD-10 code
H40.6
ICD-10 code description
Glaucoma secondary to drugs
Primary outcomes
1
Description
IOP
Timepoint
IOP measurement after 1 and 3 month
Method of measurement
Goldman Tonometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Eyedrop Bethametasone (0.1% sinadaru) every 6 hours for one month
Category
Treatment - Drugs
2
Description
Intervention group: Eyedrop Floucort (0.1%suspension Sinadaru) every 6 hours for one month
Category
Treatment - Drugs
3
Description
Intervention group: Eyedrop Lotemax (loteprednol etabonate ophthalmic suspension) 0.5% (Bausch & Lomb) every 6 hours for one month
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Eye Hospital
Full name of responsible person
Dr Hosein Sadrolsadat
Street address
Farabi Eye Hospital, Ghazvin Sq.
City
Tehran
Province
Tehran
Postal code
133661616351
Phone
+98 21 5540 0003
Email
h-hashemian@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammadali Sahraeian
Street address
Ghods st., Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8898 7381
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Hesam Hashemian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Farabi Eye Hospital, Ghazvin Sq.
City
Tehran
Province
Tehran
Postal code
133661616351
Phone
+98 21 5540 0003
Email
h-hashemian@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hesam Hashemian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Farabi hospital, Ghazvin sq, Tehran
City
Tehran
Province
Tehran
Postal code
133661616351
Phone
+98 21 4473 7065
Fax
Email
H_hashemian@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hesam Hashemian
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Farabi hospital, Ghazvin sq, Tehran
City
Tehran
Province
Tehran
Postal code
133661616351
Phone
+98 21 4473 7065
Fax
Email
H_hashemian@tums.ac.ir
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