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IRCT20220116053736N1 IRCT 2022-01-27 Kerman University of Medical Sciences Comparison of Outcomes and Complications of Phaco-Trabeculectomy (PT) With Phaco-Viscocanalostomy (PVC) in glaucoma patients Comparison of Outcomes and Complications of Phaco-Trabeculectomy (PT) With Phaco-Viscocanalostomy (PVC) in glaucoma patients: a single blind randomized controlled trial 2022-02-04 anticipated 60 Complete https://irct.ir/trial/61357 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize the participants, minimization method was used (randomization unit: individual). The random sequence was built with Minim software. In this study the allocation concealment was carried out too, Blinding description: The blinding method in this study will be single blind because the patient, eye surgeon (glaucoma specialist) and data collector (clinical assistant of eye diseases) must be aware of the type of surgery. But the information from the statistician will be kept secret. In this regard, the data gatherer will randomly name the intervention and control group A or B by and send the patients data to the statistician. N/A Condition 1: Glaucoma is a group of disorders that differ in their pathophysiology, risk factors, manifestations, treatments, and prognoses. Their common feature is progressive degeneration of the optic nerve, with loss of retinal ganglion cells, thinning of the retinal nerve fiber layer, and progressive excavation of the optic disc. Condition 2: A cataract is a cloudy area in the lens of the eye that leads to a decrease in vision. It often develop slowly and can affect one or both eyes. Intervention 1: Intervention group: First group: The first group underwent phaco-trabeculectomy (PT) surgery, in which after phycoemulsification (PE), a limbus block measuring 1×1 mm will be removed from the scleral flap. After removal of the viscoelastic material, acetylcholine chloride 1% will be injected to create pupilary stenosis and peripheral iridectomy will be performed. Two sutures with 10-0 nylon threads on both sides tightens the scleral flap. The conjunctiva will then will be sutured to the limbus with 10-0 nylon thread. Intervention 2: Intervention group: Second group: The second group will undergo Viscocanalostomy (PVC) surgery. After phycoemulsification (PE), dissection of a 4× 4-mm triangular scleral flap underneath a 5× 5 mm superficial flap will deroof Schlemm’s canal. The inner scleral flap will be pulled upward, and the floor of the canal and Descemet’s membrane will be depressed with the tip of a cellulose sponge. The membrane was then cleaved from the cornea for a distance of about 1 mm. Afterwards, the inner scleral flap will be excised. After cannulation and assurance from correct positioning, the proximal ends of the Schlemm’s canal, as well as the intrascleral space, will be filled with sodium hyaluronate according to Stegmann’s technique. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mahdi Sharifzadeh Kermani
Shafa Blvd,Shafa Hospital,Ophthalmology Department, Kerman Town
Kerman Iran (Islamic Republic of) 7618751151 +98 34 3211 5794 m.sharifzadeh@kmu.ac.ir Kerman University of Medical Sciences scientific Mahdi Sharifzadeh Kermani
Shafa Blvd, Shafa Hospital, Ophthalmology Department
Kerman Iran (Islamic Republic of) 7618751151 +98 34 3211 5794 msharif3000@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Glaucoma of Primary Open-Angle Glaucoma (POAG), Pseudoexfoliative Glaucoma (PXG), Chronic Angle Closure Glaucoma (CACG) uncontrolled with at least 2 topical medications (0.5% thymolol drops, 2 times a day) and dorsolamide 3 times daily (IOP > 21 mm Hg). Glaucoma of Primary Open-Angle Glaucoma (POAG), Pseudoexfoliative Glaucoma (PXG), Chronic Angle Closure Glaucoma (CACG) Despite using several anti-glaucoma drugs. Significant cataract (BCVA ≤20 / 60) justified by lens opacity. no limit no limit Both History of intraocular surgery such as vitreous and retinal surgery Phacomorphic glaucoma Significant corneal opacity Secondary glaucoma (Uveitis Glaucoma, neovascular glaucoma, pigmentary glaucoma) Diabetic retinopathy History of eye trauma Posterior chamber eye diseases History of phycoemulsification (PE) and glaucoma surgeries Incomplete participants' information (> 10%) Signing the written informed consent H44.51 H26.9 Absolute glaucoma Unspecified cataract Treatment - Surgery Treatment - Surgery Intervention group: First group: The first group underwent phaco-trabeculectomy (PT) surgery, in which after phycoemulsification (PE), a limbus block measuring 1×1 mm will be removed from the scleral flap. After removal of the viscoelastic material, acetylcholine chloride 1% will be injected to create pupilary stenosis and peripheral iridectomy will be performed. Two sutures with 10-0 nylon threads on both sides tightens the scleral flap. The conjunctiva will then will be sutured to the limbus with 10-0 nylon thread. Intervention group: Second group: The second group will undergo Viscocanalostomy (PVC) surgery. After phycoemulsification (PE), dissection of a 4× 4-mm triangular scleral flap underneath a 5× 5 mm superficial flap will deroof Schlemm’s canal. The inner scleral flap will be pulled upward, and the floor of the canal and Descemet’s membrane will be depressed with the tip of a cellulose sponge. The membrane was then cleaved from the cornea for a distance of about 1 mm. Afterwards, the inner scleral flap will be excised. After cannulation and assurance from correct positioning, the proximal ends of the Schlemm’s canal, as well as the intrascleral space, will be filled with sodium hyaluronate according to Stegmann’s technique. Intraocular pressure (IOP). Timepoint: At the beginning of the study (before the intervention), in the first and fourth weeks, and sixth months after surgery. Method of measurement: Goldmann tonometry. Number of drops used to reduce IOP. Timepoint: Before intervention, 1 and 4 weeks and 6 months after intervention. Method of measurement: The designed checklist. Intraoperative complications. Timepoint: From the beginning to the end of the surgery. Method of measurement: Examination by a glaucoma subspecialist. Postoperative early complications. Timepoint: In 1 and 4 weeks following surgery. Method of measurement: Examination by a glaucoma subspecialist. Postoperative late complications. Timepoint: Six months after surgery. Method of measurement: Examination by a glaucoma subspecialist. Visual Acuity. Timepoint: Before intervention, 1 and 4 weeks and 6 months after surgery. Method of measurement: Snellen chart. Need to use antiglaucoma drugs after surgery. Timepoint: In the first and fourth weeks and the sixth month after surgery. Method of measurement: Examination by a glaucoma subspecialist. Kerman University of Medical Sciences Approved 2021-12-28 Ethics committee of Kerman University of Medical Sciences Haft Bagh Alavi Blvd, campus of University of Medical Sciences Kerman Kerman Iran (Islamic Republic of)