This study is performed in order to assess the effect of Mitomycin C in high order aberration in low to moderate myopic astigmatic PRK Surgery. 130 eyes from the patients meeting eligibility criteria are assigned to receive a single drop of Mitomycin C, 0.02 % eye drop or normal saline at the end of surgery. The patients will be visited at 4th week and 6th month after the surgery. Refraction, aberrometry, and slit lamp findings are recorded and results of high order aberration and corneal hysteresis are compared between groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008094537N1
Registration date:2011-01-24, 1389/11/04
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-01-24, 1389/11/04
Registrant information
Name
Seyed-Farzad Mohammadi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 1010
Email address
sfmohamm@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2010-10-10, 1389/07/18
Expected recruitment end date
2011-06-10, 1390/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of mitomycin C on higher order aberrations in low and moderate myopic (astigmatic) PRK
Public title
Effect of mitomycin C on higher order aberrations in low and moderate myopic (astigmatic) PRK
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Myopia lower than 4 D (Spherical Eq), Astigmatism lower than 1.87 D
Exclusion criteria: Previous eye surgery, Dry eye syndrome, HOA RMS more than 0.3 microns, Anisometropia more than 1.5 D syndrome
Age
From 18 years old to 40 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
128
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
University Central Building,Ghods St, Keshavarz Blvd.
City
Tehran
Postal code
1417733161
Approval date
2010-10-03, 1389/07/11
Ethics committee reference number
89/d/130/860
Health conditions studied
1
Description of health condition studied
Myopia
ICD-10 code
H52.1
ICD-10 code description
myopia
Primary outcomes
1
Description
higher order aberration
Timepoint
1 month and 6 months
Method of measurement
Wavefront aberrometry by Zywave
Secondary outcomes
1
Description
Corneal hysteresis
Timepoint
1 month and 6 months
Method of measurement
Ocular Response Analyzer
Intervention groups
1
Description
Mitomycin C
dosage 0.02% one drop
in the end of surgery
Category
Treatment - Drugs
2
Description
Normal saline one drop
in the end of surgery
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Eye Hospital
Full name of responsible person
S-Farzad Mohammadi
Street address
Farabi hospital, Qazvin square
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical science, Farabi Eye Research Center
Full name of responsible person
Dr Ali Sadeghi-tari
Street address
Farabi Hospital,quazvin square
City
Tehran
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 science, Farabi Eye Research Center
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
Eye Research Center, Farabi Eye Hospital
Full name of responsible person
S-Farzad Mohammadi
Position
Faculty staff/Assistant Professor
Other areas of specialty/work
Street address
Farabi Eye Hospital,Qazvin Sq
City
Tehran
Postal code
1336616351
Phone
+98 21 5542 1007
Fax
+98 21 5542 1010
Email
sfmohamm@razi.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Eye Research Center, Farabi Eye Hospital
Full name of responsible person
S-Farzad Mohammadi
Position
Faculty/Assistant Professor
Other areas of specialty/work
Street address
Farabi Eye Hospital,Qazvin Sq
City
Tehran
Postal code
1336616351
Phone
+98 21 5542 1007
Fax
+98 21 5542 1010
Email
sfmohamm@razi.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Eye Research Center
Full name of responsible person
Elham Ashrafi
Position
Research Associate/MSc
Other areas of specialty/work
Street address
Farabi Eye Hospital, Qazvin Sq
City
Tehran
Postal code
1336616351
Phone
+98 21 5542 1007
Fax
+98 21 5542 1010
Email
el.ashrafi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)