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IRCT20180902040928N3 IRCT 2021-05-19 Basir eye health research center Comparing the Results of Classic and Small Sclerectomy without Graft Methods in Ahmed Glaucoma Valve Insertion: a Randomized Clinical Trial Comparing the Results of Classic and Small Sclerectomy without Graft Methods in Ahmed Glaucoma Valve Insertion: a Randomized Clinical Trial 2021-06-15 anticipated 60 Complete https://irct.ir/trial/54661 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted Block Randomization will be used. Participants are divided in two parallel groups of intervention (patients undergoing Ahmed Glaucoma Valve Insertion with small sclerectomy without graft) and the control group (the group that receives routine treatment) by using (block size = 4) random number table, Blinding description: In the present clinical trial the surgeon and patients will be aware of the classification groups (Intervention and control) and only the biostatistician who analyzed the data are blinded to label assignment of patients to each of 2 arms of the study protocol. N/A Glaucoma. Intervention 1: Intervention group: included patients undergoing Ahmed Glaucoma Valve Insertion with small sclerectomy without graft ( SSNG method) . Intervention 2: Control group: included patients undergoing conventional Ahmed Glaucoma Valve (AGV) implantation and after treatment. No - There is not a plan to make this available Justification or reason for not sharing IPD is Results will be shown in terms of published articles.
public Maryam Yadegari
4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St
Tehran Iran (Islamic Republic of) 1461783381 +98 21 6694 0404 fateme.vafaei86@gmail.com Basir eye health research center scientific Maryam Yadegari
4th floor, No 3, Shahid Sheibani Alley, after Keshavarz Blvd, Jamalzadeh Shomali St
Tehran Iran (Islamic Republic of) 1461783381 +98 21 6694 0404 fateme.vafaei86@gmail.com Basir eye health research center Iran (Islamic Republic of) All Patients with IOPs more than target pressure for which glaucoma drainage implant (GDI) surgery is planned are enrolled in the clinical trial with no age limit. no limit no limit Both Congenital glaucoma No light perception at baseline History of ocular surface infection in recent two weeks Pregnancy Breast feeding Lack of healthy conjunctiva for AGV insertion H40 Glaucoma Treatment - Surgery Treatment - Surgery Intervention group: included patients undergoing Ahmed Glaucoma Valve Insertion with small sclerectomy without graft ( SSNG method) . Control group: included patients undergoing conventional Ahmed Glaucoma Valve (AGV) implantation and after treatment. Intraocular pressure. Timepoint: First day, first week, month 1 , month 3, 6, 9 and 12 after the surgery. Method of measurement: Goldman applanation tonometry. Number of medications. Timepoint: First day, first week, month 1 , month 3, 6, 9 and 12 after the surgery. Method of measurement: Quantitative. Best corrected visual acuity (BCVA). Timepoint: First day, first week, month 1 , month 3, 6, 9 and 12 after the surgery. Method of measurement: Tumbling E-chart. Complications. Timepoint: First day, first week, month 1 , month 3, 6, 9 and 12 after the surgery. Method of measurement: Qualitative. Basir eye health research center Approved 2020-12-02 Ethics committee of Iran University of Medical Sciences Shahid Hemmat Highway Tehran Tehran Iran (Islamic Republic of)