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IRCT20161218031450N5 IRCT 2021-08-16 Tabriz University of Medical Sciences Comparison of outcomes of subtenon Mitomycin C injection Versus soaked sponges mitomycin C application in Deep Sclerectomy. Comparison of outcomes of subtenon Mitomycin C injection Versus soaked sponges mitomycin C application in Deep Sclerectomy in patients with primery open angle glaucoma and psudoexfoliation glaucoma. 2021-07-11 anticipated 40 Complete https://irct.ir/trial/57412 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the restricted randomization method of block randomization. Blocking is usually in order Balance the number of samples assigned to each of the study groups to be used. The size of all the blocks is the same and we will have 20 blocks in this two-group experiment. Randomization tool also uses random allocation software (software allocation Random) that these random sequence generation software in addition to simple randomization are able to generate random sequence by blocking method, Blinding description: In this study, patients will be divided into two groups based on the randomization form. The outcome assessor will not know how the drug was used by the surgeon. The data analyzer will also be unaware of how the drug is used in both groups. 3 Open Angle Glaucoma. Intervention 1: Intervention group: In this method, first subthenon injection of 0.1 ml of mitomycin C 0.2 mg / ml is performed and after conjugate massage, the flap is removed. Continuation of the surgical procedure is the same as routine non-penetrating deep sclerectomy. Mitomecin C Manufacturer KOREA UNITED PHARM. INC. Intervention 2: Control group: In this method, after removing the fornix base conj flap, a soaked sponge with mitomycin C 0.2 mg / ml is placed for 3 minutes and after washing, continue the surgical procedure as a routine non-penetrating deep sclerectomy. Mitomecin C Manufacturer KOREA UNITED PHARM. INC. 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 Due to the unpreparedness of data and information, decisions in this regard will be possible after data extraction and sampling.
public Ali Mostafaei
Abbasi St. Nikoocari Hospital
Tabriz Iran (Islamic Republic of) 5154645395 +98 41 3657 7330 alimostafaie@yahoo.com Tabriz University of Medical Sciences scientific Ali Mostafaei
Abbasi St. Nikoocari Hospital
Tabriz Iran (Islamic Republic of) 5154645395 +98 41 3657 7330 alimostafaie@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with open-angle glaucoma (OAG) with advanced caping and progressive visual field defects A patient with open-angle glaucoma (OAG) who needs medication to control IOP but does not tolerate medication Patients with open-angle glaucoma (OAG) whose IOP is not well controlled despite medication. Patients with open-angle glaucoma (OAG) who need multiple medications to control IOP Willingness to participate in the study (patients with informed consent) no limit no limit Both Lack of proper access to the patient for long-term follow-up Patients with any congenital abnormality of the anterior chamber angle Patients with ocular infections Patients with a history of ocular surgery Patients with uveitis Patients with corneal diseases that can affect IOP or measure it (corneal opacity, large pterygium, etc.). Patients with diabetes and hypertension Patients with neovascular glaucoma In case of any ocular or systemic complications, patients are excluded from the study H40.1 Open-angle glaucoma Treatment - Surgery Treatment - Surgery Intervention group: In this method, first subthenon injection of 0.1 ml of mitomycin C 0.2 mg / ml is performed and after conjugate massage, the flap is removed. Continuation of the surgical procedure is the same as routine non-penetrating deep sclerectomy. Mitomecin C Manufacturer KOREA UNITED PHARM. INC. Control group: In this method, after removing the fornix base conj flap, a soaked sponge with mitomycin C 0.2 mg / ml is placed for 3 minutes and after washing, continue the surgical procedure as a routine non-penetrating deep sclerectomy. Mitomecin C Manufacturer KOREA UNITED PHARM. INC. Intraocular pressure. Timepoint: Before surgery (one day, 2 weeks, 1 month, 2 months, 3 months, 6 months, after surgery). Method of measurement: Using a Goldman tonometer. Bleb apperance. Timepoint: 2 months, 3 months, 6 months after surgery. Method of measurement: IBAG(indiana Bleb Grading Scale). Tabriz University of Medical Sciences Approved 2021-06-21 Ethics Committee of Tabriz University of Medical Sciences University Street Tabriz East Azarbaijan Iran (Islamic Republic of)