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IRCT2015101024459N1 IRCT 2016-01-14 Farabi Eye Hospital Effect of mitomycin C in glaucoma shunt surgery Evaluation the Efficacy of Ahmed Glaucoma Valve Implantation with and with out Mitomycin C(MMC) during surgery in patients with glaucoma 2015-11-21 anticipated 60 Complete https://irct.ir/trial/20639 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment. N/A glaucoma. Intervention 1: 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. Intervention 2: 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.
public Doctor Ghasem Fakhraee
No. 13366, Farab eye Hospital, Qazvin square, South Kargar Avenue, Tehraan
Tehraan Iran (Islamic Republic of) +98 215540000314 drfakhraee@yahoo.com Farabi Eye Hospital scientific Doctor Ghasem Fakhraee
No.13366, Farab ieye Hospital, Qazvin square, South Kargar Avenue, Tehraan
Tehran Iran (Islamic Republic of) +98 215540000314 drfakhraee@yahoo.com Farabi Eye Hosppital Iran (Islamic Republic of) 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 17 years no limit Both H40 Glaucoma Treatment - Drugs Treatment - Drugs 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. 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. 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. 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. 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. Hyphema. Timepoint: one day and one week and one month and 3 months after intervention. Method of measurement: slit lamp exam. 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. 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. Flat chamber/transient hypotony. Timepoint: one day and one week after intervention. Method of measurement: goldmann tonometer. 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. 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. Farabi Eye Hospital Approved 2015-06-22 Tehran University of Medical Sciences Tehran University of Medical Sciences, Keshavarz Blvd, Tehran Tehran Iran (Islamic Republic of)