The aim of this study is to assess the refractive,visual and aberrometric outcomes of wavefront-guided photorefractive keratectomy( PRK) in correcting compound myopic astigmatism using Visx excimer laser system .
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202243827N4
Registration date:2012-04-05, 1391/01/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-05, 1391/01/17
Registrant information
Name
Mohammad Reza Sedghipour
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1330 6619
Email address
sedghipm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2011-01-15, 1389/10/25
Expected recruitment end date
2012-02-15, 1390/11/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcomes of wavefront-guided photorefractive keratectomy for myopic astigmatism - A randomized trial
Public title
Outcomes of wavefront-guided photorefractive keratectomy for myopic astigmatism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: Stable refraction for one year and astigmatism of 1.50-5.0 diopter. Exclusion: Patients with systemic or ocular pathologies interfering with healing process of the cornea, keratoconus, corneal dystrophy; previous trauma or surgery and pachymetry of less than 470 micron
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Gholghasht street
City
Tabriz
Postal code
Approval date
2011-01-10, 1389/10/20
Ethics committee reference number
9080
Health conditions studied
1
Description of health condition studied
Astigmatism
ICD-10 code
H52.2
ICD-10 code description
Astigmatism
Primary outcomes
1
Description
Correction of astigmatism
Timepoint
Six months after operation
Method of measurement
Diopter
Secondary outcomes
1
Description
Visual acuity
Timepoint
Six months after operation
Method of measurement
Log MAR
2
Description
Higher-order aberrations
Timepoint
Six months after operation
Method of measurement
Micron
Intervention groups
1
Description
Wavefront-guided Photorefractive Keratectomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikookari Hospital
Full name of responsible person
Mohammad Reza Sedghipour
Street address
Abbasi Avenue
City
Ttariz
2
Recruitment center
Name of recruitment center
Mehr Eye Center
Full name of responsible person
Mohammad Reza Sedghipour
Street address
Taleghani Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rasgidi
Street address
Gholghasht Street,central building of Tabriz University of Medical Sciences
City
Tabriz
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
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
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Sedghipour
Position
Associate Professor
Other areas of specialty/work
Street address
Nikookari hospital,Abbasi avenue
City
Tabriz
Postal code
Phone
+98 41 1330 6619
Fax
+98 41 1657 7336
Email
sedghipm@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Sedghipour
Position
Associate Professor
Other areas of specialty/work
Street address
Nikookari Hospital,Abbasi Ave
City
Tabriz
Postal code
Phone
+98 41 1330 6619
Fax
+98 41 1657 7336
Email
sedghipm@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Sedghipour
Position
Associate Professor
Other areas of specialty/work
Street address
Nikookari Hospital,Abbasi Ave
City
Tabriz
Postal code
Phone
+98 41 1330 6619
Fax
+98 41 1657 7336
Email
sedghipm@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)