This single-center randomized controlled double-blind clinical trial study was designed to evaluate the efficacy of Mitomycin C ( MMC) in Ahmed Glaucoma Valve( AGV) implantation. All patients older than 18 years old with uncontrolled glaucoma requiring glaucoma drainage device implantation are eligible for the study while patients younger than 18 years old ; the ones with active iris neovascularization؛ anterior staphyloma؛ Breast-feeding and pregnant women؛ patients with history of shunt surgery؛ corneal lesions which prevents IOP measurements with Goldan Tonometer were all excluded. A total number of 30 patients in the case group and 30 patients in the control group finally enrolled in the trial. The intervention could be done during surgery when after peritomy, the cotton soakedapplicator with 0.02% MMC or balanced salt solution (BSS) is placed in subtenon area for 2 minutes followed by washing the area with large amounts of serum and the implantation of Ahmed Glaucoma Valve. The IOP measurement would be the primary outcome.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015101024459N1
Registration date:2016-01-14, 1394/10/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-01-14, 1394/10/24
Registrant information
Name
Afsaneh Malekpoor
Name of organization / entity
Tehran l University of Medical Sciences -Farabi Eye Hospital
Country
Iran (Islamic Republic of)
Phone
+98 215540000314
Email address
a-malekpoor@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-11-21, 1394/08/30
Expected recruitment end date
2016-04-20, 1395/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the Efficacy of Ahmed Glaucoma Valve Implantation with and with out Mitomycin C(MMC) during surgery in patients with glaucoma
Public title
Effect of mitomycin C in glaucoma shunt surgery
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:Uncontrolled glaucoma patients under 18 years that are candidates for shunt surgery
exclusion criteria:Patients under 18 years; active iris neovascularization; anterior staphyloma; Breast-feeding and pregnancy; Previous shunt surgery; corneal lesions Which prevents IOP measurement
Age
From 17 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz Blvd, Tehran
City
Tehran
Postal code
Approval date
2015-06-22, 1394/04/01
Ethics committee reference number
IR.TUMS.REC.1394.214
Health conditions studied
1
Description of health condition studied
glaucoma
ICD-10 code
H40
ICD-10 code description
Glaucoma
Primary outcomes
1
Description
intra oclar pressure
Timepoint
before intervention and one day and one week and one month and 3 months and 6 months and 12 months after intervention
Method of measurement
goldmann tonometer
Secondary outcomes
1
Description
Tube-corneal contact
Timepoint
one day and one week and one month and 3 months and 6 moths and 12 months after intervention
Method of measurement
slit lamp exam
2
Description
The number of drugs used to control intra ocular pressure
Timepoint
one day and one week and one month and 3 months and 6 moths and 12 months after intervention
Method of measurement
history
3
Description
Hyphema
Timepoint
one day and one week and one month and 3 months after intervention
Method of measurement
slit lamp exam
4
Description
Retraction of tube from anterior chamber
Timepoint
one day and one week and one month and 3 months and 6 moths and 12 months after intervention
Method of measurement
slit lamp exam
5
Description
Tube/implant exposure
Timepoint
one day and one week and one month and 3 months and 6 moths and 12 months after intervention
Method of measurement
slit lamp exam
6
Description
Flat chamber/transient hypotony
Timepoint
one day and one week after intervention
Method of measurement
goldmann tonometer
7
Description
Choroidal effusion
Timepoint
one day and one week and one month and 3 months and 6 moths and 12 months after intervention
Method of measurement
ocular ultrasonography
8
Description
Blocked tube
Timepoint
one day and one week and one month and 3 months and 6 moths and 12 months after intervention
Method of measurement
slit lamp exam
Intervention groups
1
Description
After informing the patients about the procedure, and signing a consent form, the patients were randomly divided in two groups to receive intra-operative MMC or a Placebo. The surgical procedure consisted of a 1-stage Ahmed Glaucoma Valve implantation using a standardized surgical technique for all patients. After administration of topical anesthesia (in both groups), a fornix or limbal based cojunctival flap was applied in the superotemporal quadrant. For the control group, a cotton applicator soaked in a balanced salt solution (BSS) was placed on the Episclera, under the conjunctiva and Tenon’s capsule for a contact time of 2 minutes ,at the site where the implant plate was to be placed, followed by irrigation with 30 ml of BSS. Then the tube was positioned in the anterior chamber or the sulcus. A donor sclera or a corneal lenticule was fashioned from banked tissue and secured with interrupted 8-0 vicryl sutures over the exposed portion of the tube.
Category
Treatment - Drugs
2
Description
After informing the patients about the procedure, and signing a consent form, the patients were randomly divided in two groups to receive intra-operative MMC or a Placebo. The surgical procedure consisted of a 1-stage Ahmed Glaucoma Valve implantation using a standardized surgical technique for all patients. After administration of topical anesthesia (in both groups), a fornix or limbal based cojunctival flap was applied in the superotemporal quadrant. For the intervention group, a cotton applicator soaked in a balanced salt solution (BSS) was placed on the Episclera, under the conjunctiva and Tenon’s capsule for a contact time of 2 minutes ,at the site where the implant plate was to be placed, followed by irrigation with 30 ml of BSS. Then the tube was positioned in the anterior chamber or the sulcus. A donor sclera or a corneal lenticule was fashioned from banked tissue and secured with interrupted 8-0 vicryl sutures over the exposed portion of the tube.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Eye Hospital
Full name of responsible person
Doctor Ghasem Fakhraee
Street address
No.13366, Farabi eye Hospital, Qazvin square, South Kargar Avenue, Tehran