The study of the effects and probable side effects of anterior chamber paracentesis to control the pressure of the eye after cataract surgery by phacoemulsification
Determining the effect and possible complications of anterior chamber paracentesis in controlling ocular pressure following cataract surgery after phacoemulsification method
Design
one arm Clinical trial without control group, without blinding and without randomization, on all patients undergoing cataract surgery by phacoemulsification method.
Settings and conduct
In ophthalmology department of Shafa Hospital in Kerman, one of the educational hospitals of Kerman University of Medical Sciences, patients are included in the study with informed consent. Demographic variables recorded by data collection form and questions from the patients. Patients' eye pressure was measured 24 hours and 30 minutes before surgery. Anterior chamber paracentesis was performed in patients undergoing cataract surgery by phacoemulsification. The eye pressure also measurement 24 hours, one week and one day after the operation. in these time periods after operation patients also checked for any side effects of operation.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Informed consent
Age upper 40 years
Patient must have undergone cataract surgery by phacoemulsification
Exclusion criteria:
Informed dissatisfaction
A history of glaucoma due to the disruptive effects of diabetes and other eye diseases
Intervention groups
Patients undergoing cataract surgery by phacoemulsification method
Main outcome variables
eye pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20091030002647N2
Registration date:2020-10-10, 1399/07/19
Registration timing:retrospective
Last update:2020-10-10, 1399/07/19
Update count:0
Registration date
2020-10-10, 1399/07/19
Registrant information
Name
Ali Sharifi
Name of organization / entity
Kerman University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 7980
Email address
a_sharifi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-26, 1399/07/05
Actual recruitment start date
2020-06-30, 1399/04/10
Actual recruitment end date
2020-09-10, 1399/06/20
Trial completion date
2020-09-20, 1399/06/30
Scientific title
The study of the effects and probable side effects of anterior chamber paracentesis to control the pressure of the eye after cataract surgery by phacoemulsification
Public title
Effect of anterior chamber paracentesis to control the pressure of the eye after cataract surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
informed consent
age upper 40 years
patient must have undergone cataract surgery by phacoemulsification
Exclusion criteria:
informed dissatisfaction
history of glaucoma due to the disruptive effects of diabetes and other eye diseases
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
68
Actual sample size reached:
68
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
Ethical committee of Kerman University of Medical Sciences
Street address
Jahad blvd., Ebn-e Sina St. Vice chancellor for research,
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2020-06-01, 1399/03/12
Ethics committee reference number
IR.KMU.REC.1399.143
Health conditions studied
1
Description of health condition studied
Controlling the pressure of the eye after cataract surgery by phacoemulsification
ICD-10 code
H25
ICD-10 code description
Age-related cataract
Primary outcomes
1
Description
the pressure of the eye after cataract surgery
Timepoint
Before intervention, 1 day, 1 week and 1 month after surgery
Method of measurement
Goldmann Applanation Tonometer attached with Slit lamp biomicroscope
Secondary outcomes
1
Description
Any possible side effects
Timepoint
24 hours, one week and one month after operation
Method of measurement
Clinical Checkup
Intervention groups
1
Description
Intervention group: Anterior chamber paracentesis is performed in patients undergoing cataract surgery by phacoemulsification
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shafa hospital
Full name of responsible person
Ali Sharifi
Street address
Kosar blvd., Shafa hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 3211 5780
Email
a_sharifi@kmu.a.c.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Jahad blvd., Ebn-e sina St., Vice chancellor for research
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
abpardakhty@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Ali Sharifi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Kosar blvd., Shafa hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 1211 7980
Fax
+98 34 1211 5803
Email
a_sharifi@kmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ali Sharifi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Kosar blvd., Shafa hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 1211 7980
Fax
+98 34 1211 5803
Email
a_sharifi@kmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Ali Sharifi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Kosar blvd., Shafa hospital
City
Kerman
Province
Kerman
Postal code
7618751151
Phone
+98 34 1211 7980
Fax
+98 34 1211 5803
Email
a_sharifi@kmu.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