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IRCT20211207053323N1 IRCT 2022-10-19 Ahvaz University of Medical Sciences The effect of injection of Mitomycin c and Bevacizumab on intraocular pressure after Ahmed Glaucoma Valve (AGV) implantation surgery The effect of injection combination of Mitomycin c and Bevacizumab on outcome of intraocular pressure after Ahmed Glaucoma Valve (AGV) implantation surgery 2021-12-16 anticipated 30 Complete https://irct.ir/trial/60675 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Neovascular glaucoma. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Emad Soleimani Bayatiani
Imam Khomeini Hospital, 24 meters Street, Ophtalmology department
Ahvaz Iran (Islamic Republic of) 6155844419 +98 21 2245 4292 emadf14@yahoo.com Ahvaz University of Medical Sciences scientific Emad Soleimani Bayatiani
Imam Khomeini Hospital, 24 meters Street, Ophtalmology department
Ahvaz Iran (Islamic Republic of) 6155844419 +98 21 2245 4292 emadf14@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patient with uncontroll glaucoma and indicated for shunt 18 years no limit Both 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 H40.10X0 Unspecified open-angle glaucoma, stage unspecified Treatment - Surgery Treatment - Surgery 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. 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. 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. Ahvaz University of Medical Sciences Approved 2021-08-06 Ethics Committee of Ahwaz University of Medical Sciences Ethics Committee of Ahwaz University of Medical Sciences Ahvaz Khouzestan Iran (Islamic Republic of)