Comparative study the effect of “phacoemulsification and viscogoniosynechialysis (VGSL)” with “phacoemulsification and viscogoniosynechialysis and goniotomy” in patients with primary angle closure glaucoma (PACG).
Comparative study the effect of “phacoemulsification and viscogoniosynechialysis (VGSL)” with “phacoemulsification and viscogoniosynechialysis and goniotomy” in patients with primary angle closure glaucoma (PACG)
Design
Clinical trial with control group, single-blind, was performed in a sample of 63 eyes
Settings and conduct
In Khatam-ol-Anbia hospital, patients underwent “Phacoemulsification + VGSL” and the intervention group underwent “Phacoemulsification + VGSL + Goniotomy” which patients and researcher were single blinded .
Participants/Inclusion and exclusion criteria
patients with angle closure glaucoma as candidate for surgery with a maximum Cup to Disc Ratio (CDR) of 80% and absence of Peripheral Anterior Synechiae (PAS) in nasal quadrant
Intervention groups
In the Intervention group, the patients underwent “Phacoemulsification + viscogoniosynechialysis (VGSL) + Goniotomy” and in the control group “Phacoemulsification + viscogoniosynechialysis
Main outcome variables
the Optical coherence tomography (OCT) criteria, number of drugs used to control glaucoma and Intra Ocular Pressure (IOP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181017041367N1
Registration date:2019-02-15, 1397/11/26
Registration timing:retrospective
Last update:2019-02-15, 1397/11/26
Update count:0
Registration date
2019-02-15, 1397/11/26
Registrant information
Name
Saeed Shokoohi Rad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3728 5290
Email address
shokouhirads@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
2018-01-25, 1396/11/05
Actual recruitment end date
2018-03-06, 1396/12/15
Trial completion date
2018-09-07, 1397/06/16
Scientific title
Comparative study the effect of “phacoemulsification and viscogoniosynechialysis (VGSL)” with “phacoemulsification and viscogoniosynechialysis and goniotomy” in patients with primary angle closure glaucoma (PACG).
Public title
The effect of goniotomy on primary angle closure glaucoma
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
primary angle closure glaucoma as candidate for surgery
Exclusion criteria:
absence of Peripheral Anterior Synechiae (PAS) in nasal quadrant
maximum Cup to Disc Ratio (CDR) of 80%
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Actual sample size reached:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were blinded to the project so that they were unaware of their surgery group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Khatam Al Anbia Hospital , Shahid Gharani Boulevard , Abutaleb Crossing , Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Approval date
2017-12-24, 1396/10/03
Ethics committee reference number
IR.MUMS.fm.REC.1396.103
Health conditions studied
1
Description of health condition studied
primary angle closure glaucoma
ICD-10 code
H40.2
ICD-10 code description
Primary angle-closure glaucoma
Primary outcomes
1
Description
Intra Ocular Pressure (IOP)
Timepoint
Before surgery, one week, one month, three months and six months later
Method of measurement
Goldman tonometer
2
Description
antiglaucoma medication
Timepoint
Before surgery, one week, one month, three months and six months later
Method of measurement
questionnaire
3
Description
Optical coherence tomography (OCT) parameter
Timepoint
Before surgery, one week, one month, three months and six months later
Method of measurement
CASIA-1
Secondary outcomes
1
Description
Timepoint
Method of measurement
2
Description
antiglaucoma medication
Timepoint
Before surgery, one week, one month, three months and six months later
Method of measurement
questionnaire
3
Description
Optical coherence tomography (OCT) parameter
Timepoint
Before surgery, one week, one month, three months and six months later
Method of measurement
CASIA-1
Intervention groups
1
Description
Intervention group: “Phacoemulsification + Viscogoniosynechialysis + Goniotomy” surgery
Category
Treatment - Surgery
2
Description
Control group: “Phacoemulsification + Viscogoniosynechialysis” surgery
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam al anbia hospital
Full name of responsible person
Saeed Shokoohi Rad
Street address
Khatam Al Anbia Hospital , Abutaleb Crossing, Shahid Gharani Boulevard, Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
shokoohirads@gmail.com
Web page address
http://khatam.mums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Quraishi Building ، Daneshgah Ave , Mashhad town
City
Mashhad
Province
Razavi Khorasan
Postal code
91357345
Phone
+98 51 3841 2081
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Shokoohi Rad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
khatam al anbia hospital , Aboutaleb crossing , Shahid gharani Blvd , Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
shokoohirads@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Saeed Shokoohi Rad
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
khatam al anbia hospital , Aboutaleb crossing , Shahid gharani Blvd , Mashhad Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
shokoohirads@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Alireza Mojarrad Sani Oghaz
Position
Intern
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
khatam al anbia hospital , َAboutaleb crossing , Shahid gharani Blvd , Mashhad Town
City
mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
mojarradalireza2@gmail.com
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