comparison of clinical outcomes of phacoemulsification combined with deep sclerectomy versus phacoemulsification combined with trabeculectomy in patients with primary angle closure glaucoma, A randomized controlled clinical trial
To compare IOP reduction and need for medical treatment after surgery between groups and comparising success rate between thow groups
Design
This study is a clinical trial in two groups with different surgery. which is blinded on one side and on 60 patients who are classified into two different groups using Excel software and its randomization function. Then the results of the operation will be compared between the two groups
Settings and conduct
The patients will be randomized into two different groups and then each group will undergo a different surgery. The study site is Nikokari Eye Hospital in Tabriz.
Participants/Inclusion and exclusion criteria
Inclusion criteria
1.uncontrolled IOP despite maximal tolerable medication
2. controlled glaucoma with multiple eye drops
3.progression of disease in the visual fields
exclusion criteria
1. open angle glaucoma
2. secondary angle closure glaucoma: NVG, uveitic glaucoma
3. PACG with 360-degree PAS or having PAS at the site of DS surgery (superior)
Intervention groups
Patients with primary angle-closure glaucoma and significant cataracts
Main outcome variables
1. To compare IOP reduction and need for medical treatment after surgery between groups and comparising success rate between thow groups
2.To compare Visual acuity change after surgery between groups
3.To compare Visual field and vertical cup to disc ratio and glaucoma progression after surgery between groups
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161218031450N7
Registration date:2024-02-26, 1402/12/07
Registration timing:registered_while_recruiting
Last update:2024-02-26, 1402/12/07
Update count:0
Registration date
2024-02-26, 1402/12/07
Registrant information
Name
Ali Mostafaie
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3655 1332
Email address
mostafaeia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-01, 1402/11/12
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of clinical outcomes of phacoemulsification combined with deep sclerectomy versus phacoemulsification combined with trabeculectomy in patients with primary angle closure glaucoma, A randomized controlled clinical trial
Public title
comparison of clinical outcomes of phacoemulsification combined with deep sclerectomy versus phacoemulsification combined with trabeculectomy in patients with primary angle closure glaucoma, A randomized controlled clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Significant cataract with PACG (a closed angle on gonioscopy for at least 180 degrees of angle)
Uncontrolled IOP despite maximal tolerable medication
Controlled glaucoma with multiple eye drops and progression of disease in the visual fields
Exclusion criteria:
Open angle glaucoma
Secondary angle closure glaucoma: NVG, uveitic glaucoma
PACG with 360-degree PAS or having PAS at the site of DS surgery (superior)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using computer software (Random Allocation Software), the subjects were divided into two intervention groups through four and six blocks with an allocation ratio of 1:1 in two intervention groups (cataract combined with deep sclerectomy) or control (cataract combined with trabeculectomy) are placed. The random sequence of allocation will be produced by a person not involved in the research. And the researcher will not know about the random grouping of patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, patients will be divided into two groups based on the randomization form. The patient will not know the type of surgery that will be performed. Also, the researcher who collects the data of the study will not know what was done on the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Abbasi St. in front of police force number 12
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Approval date
2023-12-18, 1402/09/27
Ethics committee reference number
IR.TBZMED.REC.1402.732
Health conditions studied
1
Description of health condition studied
Gluocoma
ICD-10 code
H40
ICD-10 code description
Glaucoma
Primary outcomes
1
Description
Intraocular pressure
Timepoint
The first week, the first month, the third month, the sixth month and the twelfth month after the operation
Method of measurement
Using a slate lamp and a Goldman tonometer
2
Description
The patient's vision
Timepoint
Months 1, 3, 6, 12 after the operation
Method of measurement
Using the Snellen chart
3
Description
Peripheral visual field
Timepoint
6 and 12 months after the operation
Method of measurement
Using perimeter
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Deep sclerectomy surgery with cataract .In this group of patients, a surgeon with a glaucoma fellowship undergoes phacoemulsification surgery for the patient's cataract, and deep sclerectomy is performed through scleral incisions in the patient's limbus area and the adjacent conjunctiva to increase the drainage of the aqueous humor.
Category
Treatment - Surgery
2
Description
The second intervention group: combined cataract surgery with trabeculectomy.In this group of patients, a surgeon with a glaucoma fellowship undergoes phacoemulsification surgery for the patient's cataract, and trabeculectomy is performed through incisions in the limbus area of the patient and the adjacent conjunctiva with access to the space of the trabecular meshwork to increase the drainage of the aqueous humor.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Nikoukari Ophthalmology Hospital
Full name of responsible person
Milad Sheikhian
Street address
Abbasi St. in front of police force number 12
City
Tabriz
Province
East Azarbaijan
Postal code
5154545395
Phone
+98 914 574 9251
Email
miladsheikhian007@gmail.com
Web page address
https://www.tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Assistant of Tabriz University of Medical Sciences
Full name of responsible person
Doctor Parviz Shahabi
Street address
Tabriz, Azadi St., Golgasht St., Tabriz University of Medical Sciences, Central Building
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 7336
Email
parvizshahabi@gmail.com
Web page address
https://www.tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Assistant of Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Farhad Najafzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
Abbasi St. in front of police force number 12
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 7336
Email
miladsheikhian007@gmail.com
Web page address
https://www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Ali Moustafaei
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Abbasi St., in front of police force number 12, Nikoukari Ophthalmological Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 7336
Email
miladsheikhian007@gmail.com
Web page address
https://www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Milad Sheikhian
Position
Ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Tabriz Nikoukari Ophthalmology Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 7336
Email
miladsheikhian007@gmail.com
Web page address
https://www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All necessary and collected data and information will be provided as data
When the data will become available and for how long
Beginning of the access period from 1404
To whom data/document is available
Professors and colleagues and universities of medical sciences in the field of ophthalmology
Under which criteria data/document could be used
The data will be usable for ophthalmology specialists for use in the ophthalmology clinic and treatment of patients.
From where data/document is obtainable
Tabriz University of Medical Sciences, Department of Ophthalmology
What processes are involved for a request to access data/document
After completing the study, the information will be published in the form of an article.