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IRCT20161218031450N7 IRCT 2024-02-26 Research Assistant of Tabriz University of Medical Sciences comparison of clinical outcomes of phacoemulsification combined with deep sclerectomy versus phacoemulsification combined with trabeculectomy in patients with primary angle closure glaucoma, A randomized controlled clinical trial comparison of clinical outcomes of phacoemulsification combined with deep sclerectomy versus phacoemulsification combined with trabeculectomy in patients with primary angle closure glaucoma, A randomized controlled clinical trial 2024-02-01 anticipated 60 Complete https://irct.ir/trial/75266 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using computer software (Random Allocation Software), the subjects were divided into two intervention groups through four and six blocks with an allocation ratio of 1:1 in two intervention groups (cataract combined with deep sclerectomy) or control (cataract combined with trabeculectomy) are placed. The random sequence of allocation will be produced by a person not involved in the research. And the researcher will not know about the random grouping of patients, Blinding description: In this study, patients will be divided into two groups based on the randomization form. The patient will not know the type of surgery that will be performed. Also, the researcher who collects the data of the study will not know what was done on the patient. N/A Gluocoma. Intervention 1: Intervention group: Deep sclerectomy surgery with cataract .In this group of patients, a surgeon with a glaucoma fellowship undergoes phacoemulsification surgery for the patient's cataract, and deep sclerectomy is performed through scleral incisions in the patient's limbus area and the adjacent conjunctiva to increase the drainage of the aqueous humor. Intervention 2: The second intervention group: combined cataract surgery with trabeculectomy.In this group of patients, a surgeon with a glaucoma fellowship undergoes phacoemulsification surgery for the patient's cataract, and trabeculectomy is performed through incisions in the limbus area of ​​the patient and the adjacent conjunctiva with access to the space of the trabecular meshwork to increase the drainage of the aqueous humor. Yes - There is a plan to make this available What will be shared: All necessary and collected data and information will be provided as data When: Beginning of the access period from 1404 To whom: Professors and colleagues and universities of medical sciences in the field of ophthalmology Conditions: The data will be usable for ophthalmology specialists for use in the ophthalmology clinic and treatment of patients. Where to obtain: Tabriz University of Medical Sciences, Department of Ophthalmology How to obtain: After completing the study, the information will be published in the form of an article. Comments:
public Dr. Farhad Najafzadeh
Abbasi St. in front of police force number 12
Tabriz Iran (Islamic Republic of) 5154645395 +98 41 3657 7336 miladsheikhian007@gmail.com Tabriz University of Medical Sciences scientific Dr. Ali Moustafaei
Abbasi St., in front of police force number 12, Nikoukari Ophthalmological Hospital
Tabriz Iran (Islamic Republic of) 5154645395 +98 41 3657 7336 miladsheikhian007@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Significant cataract with PACG (a closed angle on gonioscopy for at least 180 degrees of angle) Uncontrolled IOP despite maximal tolerable medication Controlled glaucoma with multiple eye drops and progression of disease in the visual fields no limit no limit Both Open angle glaucoma Secondary angle closure glaucoma: NVG, uveitic glaucoma PACG with 360-degree PAS or having PAS at the site of DS surgery (superior) H40 Glaucoma Treatment - Surgery Treatment - Surgery Intervention group: Deep sclerectomy surgery with cataract .In this group of patients, a surgeon with a glaucoma fellowship undergoes phacoemulsification surgery for the patient's cataract, and deep sclerectomy is performed through scleral incisions in the patient's limbus area and the adjacent conjunctiva to increase the drainage of the aqueous humor. The second intervention group: combined cataract surgery with trabeculectomy.In this group of patients, a surgeon with a glaucoma fellowship undergoes phacoemulsification surgery for the patient's cataract, and trabeculectomy is performed through incisions in the limbus area of ​​the patient and the adjacent conjunctiva with access to the space of the trabecular meshwork to increase the drainage of the aqueous humor. Intraocular pressure. Timepoint: The first week, the first month, the third month, the sixth month and the twelfth month after the operation. Method of measurement: Using a slate lamp and a Goldman tonometer. The patient's vision. Timepoint: Months 1, 3, 6, 12 after the operation. Method of measurement: Using the Snellen chart. Peripheral visual field. Timepoint: 6 and 12 months after the operation. Method of measurement: Using perimeter. Research Assistant of Tabriz University of Medical Sciences Approved 2023-12-18 Ethics Committee of Tabriz University of Medical Sciences Abbasi St. in front of police force number 12 Tabriz East Azarbaijan Iran (Islamic Republic of)