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The effect of injection combination of Mitomycin c and Bevacizumab on outcome of intraocular pressure after Ahmed Glaucoma Valve (AGV) implantation surgery

Protocol summary

Study aim
Evaluation of the effect of simultaneous injection of Bevacizumab and Mitomycin on intraocular pressure after Ahmed glaucoma Valve (AGV) surgery and determination of relative and complete success in each group
Design
In this RCT study, 30 eyes of 30 patients in each group are examined. In this study, patients with maximal uncontrollable glaucoma and are candidates for shunt are divided into patients into two groups by block randomization: Patients receiving concomitant AGV with bevacizumab and mitomycin, patients Who do not take medication with AGV.
Settings and conduct
After surgery, patients are followed up for one week, four weeks, six weeks, eight weeks, three months and six months. After the operation, in order to evaluate the results of success in the operation, they will be divided into two complete and relative groups. The examiner does not know and will not know about the injectable drug. The single blind method is followed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with maximal uncontrollable glaucoma are candidates for shunting. Exclusion criteria: age under 18 years old; secondary neovascular glaucoma due to tumor or uveitis; follow-up less than 6 months; previous shunt devices; simultaneous injection of bevacizum in vitro IVB; non-diabetic individuals with a history of failed trabeculectomy.
Intervention groups
Patients are divided into two groups by randomization block method; patients receiving concomitant administration of bevacizumab and mitomycin with AGV and patients not receiving medication with AGV.
Main outcome variables
Intraocular pressure after AGV surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211207053323N1
Registration date: 2022-10-19, 1401/07/27
Registration timing: retrospective

Last update: 2022-10-19, 1401/07/27
Update count: 0
Registration date
2022-10-19, 1401/07/27
Registrant information
Name
Emad Soleimani bayatiani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3291 6555
Email address
emadf14@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-16, 1400/09/25
Expected recruitment end date
2022-07-31, 1401/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of injection combination of Mitomycin c and Bevacizumab on outcome of intraocular pressure after Ahmed Glaucoma Valve (AGV) implantation surgery
Public title
The effect of injection of Mitomycin c and Bevacizumab on intraocular pressure after Ahmed Glaucoma Valve (AGV) implantation surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with uncontroll glaucoma and indicated for shunt
Exclusion criteria:
Age below 18 years Neovascular glaucoma secondary to tumor or uveitis Follow up less than 6 months Previous shunt devices Simultaneous intravitreal injection of bevacizumab (IVB) Non-diabetic people with a history of failed trabeculectomy surgery
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Limited Randomization Method We will use block randomization The randomization tool is also used from sequence generation software, which is Random allocation software, random sequence generation software, in addition to simple randomization, is capable of generating random sequence by block method. In order to conceal, we use allocation concealment, which refers to the method used to perform a random sequence on the study participants, so that the allocated group is not known before the allocation of the individual. By using opaque letter envelopes sealed with a random sequence (Sequentially numbered, sealed, opaque envelopes), in this method, each of the random sequences created is recorded on a card, and the cards are placed inside the letter envelopes in order They are placed. In order to maintain a random sequence, the outer surface of the envelopes is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box. At the time of starting the registration of participants, based on the order in which eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
The method of blinding or covering a single blind is followed. In this method, the trial is planned in such a way that the participant does not know which of the two control or test groups she belongs to.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Ethics Committee of Ahwaz University of Medical Sciences
City
Ahvaz
Province
Khouzestan
Postal code
6155844419
Approval date
2021-08-06, 1400/05/15
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1400.082

Health conditions studied

1

Description of health condition studied
Neovascular glaucoma
ICD-10 code
H40.10X0
ICD-10 code description
Unspecified open-angle glaucoma, stage unspecified

Primary outcomes

1

Description
Intraocular pressure reduction percentage after surgery
Timepoint
One week, four weeks, six weeks, eight weeks, three months and 6 months are followed
Method of measurement
Applanation tonometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: to insert the AGV (scleral patch graft, scleral tunnel), the conjunctiva is cut 4 mm away from the limbus in the upper outer quadrant. 20 mg of triamcinolone is injected under the tendon around it and fixed to the sclera with 2 sutures with 0-0 silk thread. The AGV tube enters the anterior chamber from 2 mm of the limbus, so that 1-2 mm of it is inside the anterior chamber.The tube is then sutured to the sclera with 0-10 nylon thread. In the SPG method, the donor sclera is placed approximately 7 x 4 mm on the exposed part of the tube and then it is attached to the sclera with 0-10 nylon. Create a small tunnel with a 23 gauge needle, through which the tube enters the anterior chamber and the two sides of the flap are sealed with nylon 0-10.Finally, the conjunctiva and tendon are sutured continuously with 10‐10 and vicryl thread. Mitomycin is placed in the form of a sponge with a concentration of 0.04% for 2 minutes under the conjunctiva. 0.025ml is injected intrachemically with a 23-gauge needle head.
Category
Treatment - Surgery

2

Description
Control group: to insert the AGV (scleral patch graft, scleral tunnel), the conjunctiva is cut 4 mm away from the limbus in the upper outer quadrant. 20 mg of triamcinolone is injected under the tendon around it and fixed to the sclera with 2 sutures with 0-0 silk thread. The AGV tube enters the anterior chamber from 2 mm of the limbus, so that 1-2 mm of it is inside the anterior chamber.The tube is then sutured to the sclera with 0-10 nylon thread. In the SPG method, the donor sclera is placed approximately 7 x 4 mm on the exposed part of the tube and then it is attached to the sclera with 0-10 nylon. Create a small tunnel with a 23 gauge needle, through which the tube enters the anterior chamber and the two sides of the flap are sealed with nylon 0-10.Finally, the conjunctiva and tendon are sutured continuously with 10‐10 and vicryl thread.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Emad Soleimani Bayatiani
Street address
Twenty-four meter street of Imam Khomeini Hospital
City
Ahvaz
Province
Khouzestan
Postal code
6155844419
Phone
+98 21 2245 4292
Email
emadf14@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ms. Maryam Reisian
Street address
University City - Ahvaz Jundishapur University of Medical Sciences, Ground Floor, Room 4
City
Ahvaz
Province
Khouzestan
Postal code
613571579445
Phone
+98 61 3311 3817
Email
research@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Emad Soleimani Bayatiani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Imam Khomeini Hospital, 24 meters Street, Ophtalmology department
City
Ahvaz
Province
Khouzestan
Postal code
6155844419
Phone
+98 21 2245 4292
Email
emadf14@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Emad Soleimani Bayatiani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Imam Khomeini Hospital, 24 meters Street, Ophtalmology department
City
Ahvaz
Province
Khouzestan
Postal code
6155844419
Phone
+98 21 2245 4292
Email
emadf14@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Emad Soleimani Bayatiani
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
Imam Khomeini Hospital, 24 meters Street, Ophtalmology department
City
Ahvaz
Province
Khouzestan
Postal code
6155844419
Phone
+92 1224 54292
Email
emadf14@yahoo.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
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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