Protocol summary

Summary
259 patients with bilateral cataract surgery are include in the subsequent analysis. in this study we want to have improve the results of cataract surgery in the second eye. after surgery the deviation of the first eye refractive error from that predicted by intraocular lens power formulae can be use to improve the refractive results of the second eye.the patints with inadequate fallow up are exclude from the study.this methodolgy has the potential to improve the refractive outcome in the second eye of patient with cataract.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201205117743N2
Registration date: 2013-02-22, 1391/12/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-02-22, 1391/12/04
Registrant information
Name
Nooshin Bazzazi
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
00988118282682-00988118215151
Email address
nezarat@basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan univesity of medical sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2013-02-19, 1391/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Refractive outcome of cataract surgery in the second eye of patient with partially adjusted Intraocular lens power
Public title
adjustment the choice of intraocular lens power for the second eyes in cataract surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patient undergoing bilateral sequential cataract extraction between 2011 and 2012 exclusion criteria:patients with inadequate follow up after the surgery;patient with BCVA more than 20/40 after the surgery;patient who are not used the same IOL model;the patient who had phaco/IOL and an additional procedure;the patients with unilateral cataract surgery;the patient who are not operated in phaco method
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 259
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
Hamedan University of Medical Sciences
Street address
Bolvar eram - Hamedan
City
Hamedan
Postal code
3916/9/35/16/د/ب
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
3916

Health conditions studied

1

Description of health condition studied
cataract
ICD-10 code
H25.0
ICD-10 code description
senile incipient cataract

Primary outcomes

1

Description
the error of refraction in the first eye
Timepoint
preoperative and 2month postoperative
Method of measurement
examination with slit lamp

Secondary outcomes

1

Description
the error of refraction in the second eye
Timepoint
preoperation and 2month postoperation
Method of measurement
examination with slit lamp

2

Description
the choice of IOL power for the second eye
Timepoint
preoperation
Method of measurement
partially adjusted of IOL power with deviation of the first eye refractive error

Intervention groups

1

Description
intervention group:second eye with partially adjusted the IOL power
Category
Treatment - Surgery

2

Description
control group:first eye with unadjusted the IOL power
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamedan University of Medical Scieces
Full name of responsible person
Bazzazi _ Nezameslami
Street address
Hamedan Farshchian Hospital
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Bazzazi _ nezameslami
Street address
Bolvar eram - Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Nooshin Bazzazi
Position
Asistant Proffesor
Other areas of specialty/work
Street address
Hamedan Farshchian Hospital
City
Hamedan
Postal code
6516857458
Phone
+98 81 1821 5151
Fax
+98 81 1821 4141
Email
n-bazzazi@yahoo.com;bazzazi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Nooshin Bazzazi
Position
Asistant Proffesor
Other areas of specialty/work
Street address
Hamedan Farshchian Hospital
City
Hamedan
Postal code
6516857458
Phone
+98 81 1821 5151
Fax
+98 988118214141
Email
n-bazzazi@yahoo.com;bazzazi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan Univesity of Medical Sciences
Full name of responsible person
Nooshin Bazzazi - Ronak Nezameslami
Position
Asistant Proffesor
Other areas of specialty/work
Street address
Hamedan Farshchian Hospital
City
Hamedan
Postal code
6516857458
Phone
+98 81 1821 5151
Fax
+98 81 1821 4141
Email
n-bazzazi@yahoo.com;bazzazi@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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