Protocol summary

Study aim
Investigating the effect of the primary needling compared to anti-glaucoma medication therapy in the results of Ahmed glaucoma valve shunt (AGV)
Design
A clinical trial with a control group, in the form of two groups (intervention and control), randomized, the first phase on 80 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Needling of the AGV shunt installed initially by an experienced glaucoma subspecialist will be performed in the ophthalmology clinic of Tehran Imam Hossein Hospital at most once for each patient in the intervention group (after identifying the IOP above the target pressure) and then the patients will be followed up. In the subsequent follow-ups during the study, if the intraocular pressure of each patient was not controlled, anti-glaucoma medication was added to the treatment plan of that patient to prevent the damage of the disease.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: 1- Patients who recently underwent AGV shunt surgery 2- Absence of scarring and extensive fibrosis in the conjunctiva 3- Not using anti-glaucoma drugs before therapeutic intervention 4- Observing the presence of fluid around the shunt plate Exclusion criteria include: 1- Pregnancy 2- Breastfeeding 3- poor cooperation 4- Impossibility of follow-up and frequent patient visits 5- Identifying eye surface tumors in the studied eye during follow-up or some eye surface diseases that require special interventions.
Intervention groups
1- Patients with AGV who underwent primary needling. 2- Patients with AGV who received only anti-glaucoma drugs during the course of care.
Main outcome variables
Intraocular pressure, number of antiglaucoma drugs

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240217061030N1
Registration date: 2024-08-20, 1403/05/30
Registration timing: prospective

Last update: 2024-08-20, 1403/05/30
Update count: 0
Registration date
2024-08-20, 1403/05/30
Registrant information
Name
Amir Mohammadzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7762 6555
Email address
amir.mohammadzadeh74@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-10, 1403/06/20
Expected recruitment end date
2025-03-15, 1403/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of primary postoperative needling with anti-glaucoma medication in Ahmed Glaucoma valve (AGV) implantation outcome
Public title
Comparison of primary postoperative needling with anti-glaucoma medication in Ahmed Glaucoma valve (AGV) implantation outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who recently underwent AGV shunt surgery due to high intraocular pressure and glaucomatous optic nerve damage also their IOP was higher than target pressure Absence of scarring and extensive fibrosis in the conjunctiva Not using anti-glaucoma drugs before therapeutic intervention Observing the presence of fluid around the shunt plate during examination
Exclusion criteria:
Pregnancy Breastfeeding Poor cooperation during the examination with the slit lamp or during the needling operation behind the slit lamp Impossibility of follow-up and frequent patient visits Identifying eye surface tumors in the studied eye during follow-up or some eye surface diseases that require special interventions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: simple randomization Randomization Unit: Individual Randomization tool: Excel statistical software
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Central Headquarters Building, Research and Technology Vice-Chancellor, Hemat Highway, next to Milad Tower, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2020-04-26, 1399/02/07
Ethics committee reference number
IR.IUMS.REC.1399.183

Health conditions studied

1

Description of health condition studied
Glaucoma
ICD-10 code
H40.11
ICD-10 code description
Primary open-angle glaucoma

Primary outcomes

1

Description
Intraocular pressure
Timepoint
1, 3, 6 months after the intervention
Method of measurement
Goldman tonometry

Secondary outcomes

1

Description
Number of antiglaucoma drugs
Timepoint
1, 3, 6 months after the intervention
Method of measurement
Counting

Intervention groups

1

Description
Intervention group: All needling procedures for all patients with AGV behind the slit lamp device after local anesthesia with tetracaine drops, using a 27-gauge needle head by creating an incision in Tenon's capsule and reforming the bleb related to AGV by Only one experienced person (glaucoma fellowship) performed.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Amir Mohammadzadeh
Street address
Shahid Madani St, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Fax
Email
amir.mohammadzadeh74@gmail.com
Web page address
http://www.ehmc.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Shahid Arabi St, Yemen St Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1939546310
Phone
+98 21 2243 9780
Fax
+98 21 2243 9780
Email
amir.mohammadzadeh74@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mohammadzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Imam Hossein Hospital, Shahid Madani St, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
amir.mohammadzadeh74@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Yadgari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Imam Hossein Hospital, Shahid Madani St, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
0098 21 73430
Email
maryam.yadgari@yahoo.ie

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Amir Mohammadzadeh
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Imam Hossein Hospital, Shahid Madani St, Tehran
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 7343 0000
Email
amir.mohammadzadeh74@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
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