The aim of this study is to compare the corneal and scleral incisions in cataract surgery on astigmatism and aberrations. 80 eyes of 40 patients with senile cataract are randomly selected for phacoemulsification through the corneal or scleral incisions between December 2009 and December 2010. Patients with any ocular pathology are excluded. Primary outcomes are correction of astigmatism and corneal aberrations.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138903213827N2
Registration date:2010-06-11, 1389/03/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-06-11, 1389/03/21
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
2009-12-22, 1388/10/01
Expected recruitment end date
2010-12-22, 1389/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of corneal and scleral incisions in cataract surgery on astigmatism & aberrations
Public title
Effect of corneal and scleral incisions in cataract surgery on astigmatism & aberrations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: senile cataract and astigmatism less than 1.25 diopter
Exclusion criteria: ocular pathology, age less than 6
Age
From 60 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
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
6028/4/5
Health conditions studied
1
Description of health condition studied
Astigmatism in cataract surgery
ICD-10 code
H52
ICD-10 code description
Disorders of refraction
2
Description of health condition studied
Corneal aberrations
ICD-10 code
H59
ICD-10 code description
post procedural disorders of the eye
Primary outcomes
1
Description
astigmatism
Timepoint
before operation and six months after operation
Method of measurement
keratometry
2
Description
corneal aberration
Timepoint
before operation and six months after operation
Method of measurement
galilei
Secondary outcomes
1
Description
visual acuity
Timepoint
before operation and six months after operation
Method of measurement
Snelen chart
Intervention groups
1
Description
corneal incision in cataract surgery
Category
Treatment - Surgery
2
Description
scleral incision in cataract surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikookari Hospital
Full name of responsible person
Dr. Mohammad Reza Sedghipour
Street address
Abbasi avenue
City
TABRIZ
2
Recruitment center
Name of recruitment center
Mehr eye center
Full name of responsible person
Dr. Mohammad Reza Sedghipour
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
Ghlghasht street
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
Dr. Mohammad Reza Sedghipour
Position
Associate professor
Other areas of specialty/work
Street address
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
Dr. Mohammad Reza Sedghipour
Position
Associate professor
Other areas of specialty/work
Street address
Abbasi avenue
City
Tabriz
Postal code
Phone
+98 41 1657 5609
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
Dr. Behzad Fallahi Motlagh
Position
Assistant professor
Other areas of specialty/work
Street address
Abbasi avenue
City
Tabriz
Postal code
Phone
+98 41 1657 5609
Fax
+98 41 1657 7336
Email
BFM1346@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)