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IRCT20080901001154N2 IRCT 2020-10-07 Mashhad University of Medical Sciences Anterior segment parameters following surgical management in angle closure glaucoma Comparison of anterior segment morphological changes using anterior segment optical coherence tomography (ASOCT) in patients with coexisting primary angle closure glaucoma and cataract, undergoing phacoemulsification and phacotrabeculectomy. 2015-06-20 anticipated 60 Complete https://irct.ir/trial/50893 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: The main purpose of the study is to investigate the effect of either surgical method on the anterior chamber drainage angle, Randomization description: Envelops, containing random numbers were prepared and sealed. ،To pick the number, the first number was selected by a pen with closed eyes and then successive numbers were selected from the table (eg, if the first number was 7, we moved to the right and down of that digit and selected every 7th number to reach the required 60 envelops with random numbers). For each participants, a new envelope was opened and those with odd number allocate to phacoemulsification group and those with even number allocated to the phacotrabeculectomy group. N/A Condition 1: Glaucoma. Condition 2: cataract. Intervention 1: In intervention group, the patients undergo phacoemulsification cataract surgery with a temporal incision and posterior chamber intraocular lens (PCIOL) implantation in the capsular bag. At the conclusion of cataract surgery and in the same session, a superior fornix-based trabeculectomy with intraoperative mitomycin-c is done for the patients. Intervention 2: In the control group, the patients undergo temporal phacoemulsification and in the bag PCIOL implantation. No separate, additional glaucoma surgery is done in this group. Yes - There is a plan to make this available What will be shared: Deidentified, anonymous participants data are available in a MS Excel file. When: One year after publication of the article. To whom: Other researcher, upon written request Conditions: Accreditation and meta-analysis Where to obtain: Written request, directed to corresponding person or PI How to obtain: Upon approval of the request by Vice chancellor of Research at MUMS and the legal authorities, the information would be send to the requester. Comments:
public Ramin Daneshvar, MD, MSc
Gharani Blvd
Mashhad Iran (Islamic Republic of) 9195961151 0098513289911 daneshvarr@mums.ac.ir Mashhad University of Medical Sciences scientific Ramin Daneshvar, MD, MS
Gharani Blvd
Mashhad Iran (Islamic Republic of) 9195961151 +98 51 3728 9911 daneshvarr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Primary angle closure glaucoma Cataract 40 years no limit Both Any previous intraocular surgery (except laser iridotomy) History of ocular trauma History of other ocular diseases (except cataract and glaucoma) H40 H25 Glaucoma Age-related cataract Treatment - Surgery Treatment - Surgery In intervention group, the patients undergo phacoemulsification cataract surgery with a temporal incision and posterior chamber intraocular lens (PCIOL) implantation in the capsular bag. At the conclusion of cataract surgery and in the same session, a superior fornix-based trabeculectomy with intraoperative mitomycin-c is done for the patients. In the control group, the patients undergo temporal phacoemulsification and in the bag PCIOL implantation. No separate, additional glaucoma surgery is done in this group. Intraocular pressure (IOP). Timepoint: Postoperative 1st week, 1st month, 6th and month. Method of measurement: IOP measurement with Goldmann applanation tonometer. Angle opening distance at 500 micron (AOD500). Timepoint: Before surgery, 1 week, 1 month and 6 months after surgery. Method of measurement: Measuring AOD using Casia AS-OCT device (Tomey). Trabecular iris angle at 500 micron (TIA500). Timepoint: Before surgery; 1 week, 1 month and 6 months after surgery. Method of measurement: Measuring TIA using Casia ASOCT (Tomey). Trabecular-iris surface area (TISA). Timepoint: Before surgery; 1 week, 1 month and 6 months after surgery. Method of measurement: Measuring TIA using Casia ASOCT (Tomey). Mashhad University of Medical Sciences Approved 2015-05-21 Ethics Committee, Mashhad University of Medical Sciences Ghoreishi building, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)