Effect of YAG capsulotomy on anterior segment parameters and lenticular astigmatism in pseudophakic patients with posterior capsule opacity: a before-after clinical trial
To assess the effect of YAG capsulotomy on anterior segment parameters and lenticular astigmatism in pseudophakic patients with posterior capsule opacity
Design
This is a before-after clinical trial in which 26 eligible patients will be recruited.
Settings and conduct
The eligible patients with posterior capsule opacity who will refer to Sina Hospital in Hamadan City during the study period will be enrolled in this before-after trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age of 18 to 75 years
Posterior capsule opacity
Visual impairment
Indication of Laser TAG capsulotomy
Exclusion criteria:
History of cataract complicated surgery
Diabetes
Other eye diseases
The history of eye trauma
Intensive nystagmus
Mental retardation
Intervention groups
Intervention group:
Surgery of cataract and lens adjustment using laser YAG capsulotomy
Control group:
In comparison with before intervention
Main outcome variables
Refractive errors; depth of the anterior chamber; volume of the anterior chamber; size of the cornea b; pupil size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N288
Registration date:2019-07-07, 1398/04/16
Registration timing:retrospective
Last update:2019-07-07, 1398/04/16
Update count:0
Registration date
2019-07-07, 1398/04/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of YAG capsulotomy on anterior segment parameters and lenticular astigmatism in pseudophakic patients with posterior capsule opacity: a before-after clinical trial
Public title
Effect of YAG capsulotomy on anterior segment parameters and lenticular astigmatism in pseudophakic patients with posterior capsule opacity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 75 years
Posterior capsule opacity
Visual impairment
Indication of Laser TAG capsulotomy
Exclusion criteria:
History of cataract complicated surgery
Diabetes
Other eye diseases
The history of eye trauma
Intensive nystagmus
Mental retardation
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
IR.UMSHA.REC.1398.050
Health conditions studied
1
Description of health condition studied
Cataract
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
Comparison of the refractive errors
Timepoint
Before the intervention and 3 months later
Method of measurement
By clinical examination
2
Description
Comparison of the depth of the anterior chamber
Timepoint
Before the intervention and 3 months later
Method of measurement
By clinical examination
3
Description
Comparison of the volume of the anterior chamber
Timepoint
Before the intervention and 3 months later
Method of measurement
By clinical examination
4
Description
Comparison of the size of the cornea
Timepoint
Before the intervention and 3 months later
Method of measurement
By clinical examination
5
Description
Comparison of the pupil size
Timepoint
Before the intervention and 3 months later
Method of measurement
By clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Surgery of cataract and lens adjustment using laser YAG capsulotomy
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan City
Full name of responsible person
Milad Molaii
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
molaiimilad@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Milad Molaii
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
molaiimilad@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Mahdi Alizadeh
Position
Ophthalmologist
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
mahaliz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available