the aim of this study is to compare the visual, refractive and aberrometric results of cross-cylinder and single method of photorefractive keratectomy in correcting medium-high astigmaism using Nidek excimer laser system.The right or left eye of fifty patients would be allocated randomly to one of the study methods.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201107103827N3
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
2007-11-06, 1386/08/15
Expected recruitment end date
2009-06-05, 1388/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of cross-cylinder and single method of photorefractive keratectomy in correcting medium-high astigmatism :A randomized clinical study
Public title
Comparison of cross-cylinder and single method of photorefractive keratectomy in correcting medium-high astigmatism
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age more than 20 years, refractive stability for at least one year and regular and symmetric astigmatism more than 1.50 diopters
Exclusion criteria: corneal thickness less than 480 micron, keratoconus or suspected keratoconus, active ocular disease and systemic collagen disease
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:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
www.clinicaltrials.gov
Secondary trial Id
NCT00663923
Registration date
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
2007-11-01, 1386/08/10
Ethics committee reference number
8643
Health conditions studied
1
Description of health condition studied
Medium-high astigmatism
ICD-10 code
H52.2
ICD-10 code description
Astigmatism
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
Snellen chart
2
Description
Visual aberrations
Timepoint
Preoperative and six months postoperative
Method of measurement
Aberrometry
Intervention groups
1
Description
cross-cylinder photorefractive keratectomy
Category
Treatment - Surgery
2
Description
single(monotoric) photorefractive keratectomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mehr eye center
Full name of responsible person
Afshin Lotfi
Street address
Abbasi Avenue
City
Tabriz
2
Recruitment center
Name of recruitment center
Nikookari Hospital
Full name of responsible person
Afshin LOTFI
Street address
Abbasi Avenue
City
tABRIZ
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Rashidi
Street address
Gholghasht street,second 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
Afshin LOTFI
Position
Assisstant professor
Other areas of specialty/work
Street address
Nikookari Hospital,Abbasi avenue
City
Tabriz
Postal code
Phone
+98 41 1657 5609
Fax
+98 41 1657 7336
Email
aafshinlotfi48@gmail.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)