This single blinded, stratified, randomized clinical trial was designed to evaluate safety and efficacy of Ahmed Glaucoma Valve Insertion with small sclerectomy without graft ( SSNG method) in Controlling Post-Operative Elevated Intraocular Pressure
Design
A randomized, single blinded, parallel trial
Settings and conduct
All procedures are performed by unique glaucoma surgeon (M.Yadgari) in Basir eye clinic. data analyzer is blinded in this study.
Participants/Inclusion and exclusion criteria
All Patients with IOPs more than target pressure for which glaucoma drainage implant (GDI) surgery was planned are enrolled in the clinical trial with no age limit. Exclusion criteria are congenital glaucoma, no light perception at baseline, history of ocular surface infection in recent two weeks, pregnancy, breast feeding, lack of healthy conjunctiva for AGV insertion.
Intervention groups
1. Group A included patients undergoing conventional Ahmed Glaucoma Valve (AGV) implantation and after treatment .
2. Group B included patients undergoing Ahmed Glaucoma Valve Insertion with small sclerectomy without graft ( SSNG method) .
Main outcome variables
Intraocular pressure (IOP); possible need to anti-glaucoma medications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180902040928N3
Registration date:2021-05-19, 1400/02/29
Registration timing:prospective
Last update:2021-05-19, 1400/02/29
Update count:0
Registration date
2021-05-19, 1400/02/29
Registrant information
Name
Maryam Yadgari
Name of organization / entity
Basir eye health research center
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 0404
Email address
sobhanisoheila@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-15, 1400/03/25
Expected recruitment end date
2024-06-14, 1403/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Results of Classic and Small Sclerectomy without Graft Methods in Ahmed Glaucoma Valve Insertion: a Randomized Clinical Trial
Public title
Comparing the Results of Classic and Small Sclerectomy without Graft Methods in Ahmed Glaucoma Valve Insertion: a Randomized Clinical Trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All Patients with IOPs more than target pressure for which glaucoma drainage implant (GDI) surgery is planned are enrolled in the clinical trial with no age limit.
Exclusion criteria:
Congenital glaucoma
No light perception at baseline
History of ocular surface infection in recent two weeks
Pregnancy
Breast feeding
Lack of healthy conjunctiva for AGV insertion
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization will be used. Participants are divided in two parallel groups of intervention (patients undergoing Ahmed Glaucoma Valve Insertion with small sclerectomy without graft) and the control group (the group that receives routine treatment) by using (block size = 4) random number table.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present clinical trial the surgeon and patients will be aware of the classification groups (Intervention and control) and only the biostatistician who analyzed the data are blinded to label assignment of patients to each of 2 arms of the study protocol.
Placebo
Not used
Assignment
Parallel
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
Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-12-02, 1399/09/12
Ethics committee reference number
IR.IUMS.REC.1399.968
Health conditions studied
1
Description of health condition studied
Glaucoma
ICD-10 code
H40
ICD-10 code description
Glaucoma
Primary outcomes
1
Description
Intraocular pressure
Timepoint
First day, first week, month 1 , month 3, 6, 9 and 12 after the surgery
Method of measurement
Goldman applanation tonometry
2
Description
Number of medications
Timepoint
First day, first week, month 1 , month 3, 6, 9 and 12 after the surgery
Method of measurement
Quantitative
Secondary outcomes
1
Description
Best corrected visual acuity (BCVA)
Timepoint
First day, first week, month 1 , month 3, 6, 9 and 12 after the surgery
Method of measurement
Tumbling E-chart
2
Description
Complications
Timepoint
First day, first week, month 1 , month 3, 6, 9 and 12 after the surgery
Method of measurement
Qualitative
Intervention groups
1
Description
Intervention group: included patients undergoing Ahmed Glaucoma Valve Insertion with small sclerectomy without graft ( SSNG method) .
Category
Treatment - Surgery
2
Description
Control group: included patients undergoing conventional Ahmed Glaucoma Valve (AGV) implantation and after treatment.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
Maryam Yadegari
Street address
Madani Avenue, Tehran.
City
Tehran
Province
Tehran
Postal code
1617763141
Phone
+98 21 6694 0404
Email
maryam.yadgari@yahoo.ie
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Basir eye health research center
Full name of responsible person
Ahmad Shojaei Baghini
Street address
4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St
City
Tehran
Province
Tehran
Postal code
1418643561
Phone
+98 21 6694 0404
Email
info@behrc.ir
Web page address
https://behrc.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Basir eye health research center
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Basir eye health research center
Full name of responsible person
Maryam Yadegari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St
City
Tehran
Province
Tehran
Postal code
1461783381
Phone
+98 21 6694 0404
Fax
Email
fateme.vafaei86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Basir eye health research center
Full name of responsible person
Maryam Yadegari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St
City
Tehran
Province
Tehran
Postal code
1461783381
Phone
+98 21 6694 0404
Fax
Email
fateme.vafaei86@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Basir eye health research center
Full name of responsible person
Maryam Yadegari
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St
City
Tehran
Province
Tehran
Postal code
1461783381
Phone
+98 21 6694 0404
Fax
Email
fateme.vafaei86@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Results will be shown in terms of published articles.