The aim of present study is to compare the safety and efficacy of two Nd: YAG laser capsulotomy techniques.
The main inclusion criteria were having cataract surgery at least 3 months ago. the population were included patients with history of cataract in 3 month ago.
In this randomized clinical trial, sample size was 100 eyes of patients with posterior capsular opacification. The eyes were randomly divided in two groups. 50 eyes were selected to undergo a cruciate capsulotomy and the other 50 eyes were selected to undergo a circular capsulotomy.
Main outcome were best-corrected visual acuity, intraocular pressure, amount of energy used and floater symptoms or glare.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201207037466N4
Registration date:2016-11-26, 1395/09/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-11-26, 1395/09/06
Registrant information
Name
Reza Rezaei
Name of organization / entity
Ophtalmologist
Country
Iran (Islamic Republic of)
Phone
+98 912 239 1814
Email address
dr.rezarezaei@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences, Deputy of Education and research
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Nd: YAG laser posterior capsulotomy with two Cruciate and Circular techniques
Public title
Detection of different surgery method on visual acuity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age over 40 year; 3 months after having cataract surgery in 3 month ago; PCO≥2;
Exclusion Criteria: Not wanting to take part in the study; Having adverse effect;
Age
From 40 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Sq., Arak, Iran
City
Arak
Postal code
Approval date
2014-09-23, 1393/07/01
Ethics committee reference number
93-176-8
Health conditions studied
1
Description of health condition studied
cataract
ICD-10 code
H25
ICD-10 code description
Senile cataract
Primary outcomes
1
Description
visual acuity
Timepoint
1 day after injection,1 week, 1 month & 3 month
Method of measurement
log mar
Secondary outcomes
1
Description
IOP
Timepoint
1 day after injection,1 week, 1 month & 3 month
Method of measurement
Tonometer
Intervention groups
1
Description
Posterior capsulotomy by cross method
Category
Treatment - Surgery
2
Description
Posterior capsulotomy with ring method
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Amir Kabir Hospital
Full name of responsible person
Dr Reza Rezaeie
Street address
Amir Kabir Hospital, Alamolhoda Street, Shaheed Shroudi Street, Arak, Iran
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Science
Full name of responsible person
Dr Mohammad Rafiei
Street address
Arak University of Medical Science, Basij Sq., Arak, Iran
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak University of Medical Science
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
Arak University of Medical Sciences
Full name of responsible person
Dr Reza Rezaei
Position
Assistant Professor/ophthalmologist
Other areas of specialty/work
Street address
Amir Kabir Hospital, Alamolhoda Street, Shaheed Shroudi Street, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3313 4717
Fax
Email
dr.rezarezaei@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Reza Rezaei
Position
Ophtalmologist/Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital, Alamolhoda Street, Shaheed Shroudi Street, Arak, Iran
City
Arak
Postal code
Phone
+98 86 3313 4715
Fax
Email
dr.rezarezaei@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Reza Rezaei
Position
Ophtalmologist,Assistant Professor
Other areas of specialty/work
Street address
Amir Kabir Hospital, Alamolhoda Street, Shaheed Shroudi Street, Arak, Iran
City
Arak
Postal code
0098
Phone
+98 86 3313 4717
Fax
Email
dr.rezarezaei@arakmu.ac.ir
Web page address
portal.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)