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IRCT20200704047997N1 IRCT 2020-11-08 Mashhad University of Medical Sciences Comparison of results and complications of Phacoviscocanalostomy surgery with and without implants in patients with open angle glaucoma Comparison of results and complications of Phacoviscocanalostomy surgery with and without implants in patients with open angle glaucoma 2020-08-05 anticipated 60 Complete https://irct.ir/trial/49783 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method The envelope method will be used for random assignment of patients in study groups. In this way, random numbers will be prepared with the help of randomize.com and will be placed in sealed envelopes. The lid of the envelope is closed and the contents of the envelope will not be visible from the outside. The secretary of the clinic will deliver one of the envelopes to the patient and the surgeon will study the patient in one of the two groups based on the contents of the envelope, Blinding description: Analysts will not know if patients are exposed or controlled. Subjects will not be aware of their exposure or control. N/A Open angle glaoucoma. Intervention 1: Intervention group: In this group, in addition to Phacoviscocanalostomy, they undergo intrascleral implants.In this intervention, a part of the Ahmed valve tube, which remains from the previous AGV operation and is practically useless, is sterilized and divided into two parts and the end 4 mm is cut. This tube is placed in the suprachroidal space. Intervention 2: Control group: In this group, only Phacoviscocanalostomy is performed and no implant is used. Yes - There is a plan to make this available What will be shared: All data can be shared When: Access period starts 3 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: - Where to obtain: Ali Bagheri Asl ali.bagheri7181@gmail.com How to obtain: Send the request via email and state the reason for the request Comments:
public Ali Bagheri Asl
Khatam-Al-Anbia Eye Hospital
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 9911 ali.bagheri7181@gmail.com Mashhad University of Medical Sciences scientific Ali Bagheri Asl
Aboutaleb Crossroads, Khatam Al-Anbia Ophthalmology Hospital
Mashhad Iran (Islamic Republic of) 9195965919 +98 51 3728 1401 ali.bagheri7181@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Patient satisfaction Open angle glaoucoma Indication of glaucoma surgery No previous surgery (glaucoma surgeries) no limit no limit Both Complications during surgery Impossibility to follow up Lack of patient cooperation during follow-up H40.1 Open-angle glaucoma Treatment - Devices N/A Intervention group: In this group, in addition to Phacoviscocanalostomy, they undergo intrascleral implants.In this intervention, a part of the Ahmed valve tube, which remains from the previous AGV operation and is practically useless, is sterilized and divided into two parts and the end 4 mm is cut. This tube is placed in the suprachroidal space. Control group: In this group, only Phacoviscocanalostomy is performed and no implant is used. Bleb area measurement. Timepoint: Six months after surgery. Method of measurement: By anterior segment OCT. Mashhad University of Medical Sciences Approved 2019-12-18 Ethics Committee of Mashhad University of Medical Sciences Aboutaleb Crossroads, Khatam Al-Anbia Ophthalmology Hospital mashhad Razavi Khorasan Iran (Islamic Republic of)