The aim of this study is to compare the visual and refractive results of wavefront-guided and cross-cylinder photorefractive keratectomy by visx and nidek laser systems in correcting medium-high astigmatism. 50 eyes of 25 patients with stable refraction are randomly selected for wavefront-guided photorefractive keratectomy between December 2009 and December 2010. Then the results will be compared with findings of 48 patients who had been previously operated by cross-cylinder approach two years ago. Patients with pachymetry less than 470 microns are excluded. Correction of astgmatism is the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902083827N1
Registration date:2009-11-22, 1388/09/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-11-22, 1388/09/01
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
2009-11-22, 1388/09/01
Expected recruitment end date
2010-11-22, 1389/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of wavefront-guided and cross-cylinder photorefractive keratectomy in correcting medium-high astigmatism
Public title
Comparison of wavefront-guided and cross-cylinder photorefractive keratectomy in correcting medium-high astigmatism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: stable refraction, astigmatism more than 1.50 diopter, age 20-50 years
Exclusion criteria: any ocular pathology, pachymetry less than 470 micron, connective tissue disease, asymmetric astigmatism, tear film abnormality
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:
98
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
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
empty
Ethics committee reference number
3099/4/5
Health conditions studied
1
Description of health condition studied
medium-high astigmatism
ICD-10 code
H52
ICD-10 code description
Disorders of refraction
Primary outcomes
1
Description
correction of astigmatism
Timepoint
preoperative and six months postoperative
Method of measurement
refraction
Secondary outcomes
1
Description
visual acuity
Timepoint
preoperative and six months postoperative
Method of measurement
snelen chart
2
Description
visual aberrations
Timepoint
preoperative and six months postoperative
Method of measurement
aberrometry
Intervention groups
1
Description
wavefront-guided photorefractive keratectomy
Category
Treatment - Surgery
2
Description
cross-cylinder photorefractive keratectomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikookari Hospital
Full name of responsible person
Rana Sorkhabi,MD
Street address
Abbasi avenue
City
Tabriz
2
Recruitment center
Name of recruitment center
Mehr Hospital
Full name of responsible person
Mohammad Reza Sedghipour,MD
Street address
Taleghani street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Secretery,Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Gholghasht street, second central building, 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
Research Secretery,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, MD
Position
Associate Professor
Other areas of specialty/work
Street address
Nikookari Hospital, Abbasi avenue,
City
Tabriz
Postal code
Phone
+98 41 1657 5609
Fax
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
Rana Sorkhabi, MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Nikookari Hospital, Abbasi avenue
City
Tabriz
Postal code
Phone
+98 41 1657 5609
Fax
Email
sorkhabi_r@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
Rana Sorkhabi, MD
Position
Assistant Professor
Other areas of specialty/work
Street address
Abbasi avenue
City
Tabriz
Postal code
Phone
+98 41 1657 5609
Fax
Email
sorkhabi_r@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)