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IRCT2016121831450N1 IRCT 2017-04-18 Vice Chancellor for research of Tabriz University of Medical Sciences Compare the effects of Avastin and Avastin combined with methylcellulose in intraocular pressure after Non-penetrating glaucoma surgery Compare the effects of Avastin and Avastin combined with methylcellulose in intraocular pressure after Non-penetrating glaucoma surgery 2017-02-19 anticipated 30 Complete https://irct.ir/trial/24732 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A glaucoma. Intervention 1: Intervention group 1: patients in this group will be put under general anesthesia. At first, a fornix-based conjunctival flap is created. Then, a 4x 4 mm outer parabolic flap, approximately 200 μm thick will be dissected followed by an inner concentrically 2 x 2mm scleral flap sculpted beneath the previous one. The internal flap should be dissected deep enough to have a dark reflex from the underlying choroid. The subconjunctival َAvastin group receive of 1.25 mg of bevacizumab, subconjuctival injection at the end of surgery, while the cut is advanced anteriorly, Schlemm’s canal is de-roofed. The two ostia of Schlemm’s canal are then cannulated with the specific 190 μm cannulaand Schlemm’s canal is dilated by slow and repeated injections of high-molecular-weight sodium hyaluronate . By gently pulling the inner scleral flap upwards and delicately depressing the floor of the canal and Descemet’s membrane with the tip of a cotton swab, the membrane itself is then cleaved from the cornea and the cleavage is advanced in clear cornea for approximately 1 mm, thus creating the so-called ‘trabeculo-descemetic window’ .As soon as the window is completed, the inner scleral flap is excised. The next step is the sealing of the lake, which is obtained by tightly suturing the outer scleral flap with seven 10-0 nylon stitches. High-molecular-weight sodium hyaluronate is then injected underneath the flap to fill the intrascleral space temporarily, preventing it from collapsing and scarring in the early post-operative period. Finally, the conjunctiva is sutured in place. Intervention 2: Intervention group 2: patients in this group will be put under general anesthesia. At first, a fornix-based conjunctival flap is created. Then, a 4x 4 mm outer parabolic flap, approximately 200 μm thick will be dissected followed by an inner concentrically 2 x 2mm scleral flap sculpted beneath the previous one. The internal flap should be dissected deep enough to have a dark reflex from the underlying choroid. The subconjunctival bevacizumab (ScB) group receive of 1.25 mg/ 0.3 ml of bevacizumab, subconjuctival injection at the end of surgery, while the cut is advanced anteriorly, Schlemm’s canal is de-roofed. The two ostia of Schlemm’s canal are then cannulated with the specific 190 μm cannulaand Schlemm’s canal is dilated by slow and repeated injections of high-molecular-weight sodium hyaluronate . By gently pulling the inner scleral flap upwards and delicately depressing the floor of the canal and Descemet’s membrane with the tip of a cotton swab, the membrane itself is then cleaved from the cornea and the cleavage is advanced in clear cornea for approximately 1 mm, thus creating the so-called ‘trabeculo-descemetic window’ .As soon as the window is completed, the inner scleral flap is excised. The next step is the sealing of the lake, which is obtained by tightly suturing the outer scleral flap with seven 10-0 nylon stitches. High-molecular-weight sodium hyaluronate is then injected underneath the flap to fill the intrascleral space temporarily, preventing it from collapsing and scarring in the early post-operative period. Finally, the conjunctiva is sutured in place.
public neda moghaddam
Central building of the university, Golgasht street, Azadi street, Tabriz
tabriz Iran (Islamic Republic of) 5166616471 +98 41 3657 1670 ghmoghaddam@tabrizu.ac.ir Tabriz University of Medical Sciences scientific Ali Mostafaie
Central building of the university, Golgasht street, Azadi street, Tabriz
tabriz Iran (Islamic Republic of) 5166616471 +98 41 3335 5921 info@elibrary.tbzmed.ac.ir; dln@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria:patients with open-angle glaucoma and uncontrolled IOP on maximally tolerated medical therapy with uncontrolled IOP Exclusion criteria:Patientswith previous glaucoma and cataract surgery,previous surgery due to trauma,angle closure glaucoma, who are less than 40 years؛ Diabetes;uveitis,Collagen vascular disease,Neovascular glaucoma,end stage glaucoma 40 years no limit Both H40.1 Primary open-angle glaucoma Glaucoma (primary)(residual stage): capsular with pseudoexfoliation of lens chronic simple low-tension pigmentary Treatment - Drugs Treatment - Drugs Intervention group 1: patients in this group will be put under general anesthesia. At first, a fornix-based conjunctival flap is created. Then, a 4x 4 mm outer parabolic flap, approximately 200 μm thick will be dissected followed by an inner concentrically 2 x 2mm scleral flap sculpted beneath the previous one. The internal flap should be dissected deep enough to have a dark reflex from the underlying choroid. The subconjunctival َAvastin group receive of 1.25 mg of bevacizumab, subconjuctival injection at the end of surgery, while the cut is advanced anteriorly, Schlemm’s canal is de-roofed. The two ostia of Schlemm’s canal are then cannulated with the specific 190 μm cannulaand Schlemm’s canal is dilated by slow and repeated injections of high-molecular-weight sodium hyaluronate . By gently pulling the inner scleral flap upwards and delicately depressing the floor of the canal and Descemet’s membrane with the tip of a cotton swab, the membrane itself is then cleaved from the cornea and the cleavage is advanced in clear cornea for approximately 1 mm, thus creating the so-called ‘trabeculo-descemetic window’ .As soon as the window is completed, the inner scleral flap is excised. The next step is the sealing of the lake, which is obtained by tightly suturing the outer scleral flap with seven 10-0 nylon stitches. High-molecular-weight sodium hyaluronate is then injected underneath the flap to fill the intrascleral space temporarily, preventing it from collapsing and scarring in the early post-operative period. Finally, the conjunctiva is sutured in place. Intervention group 2: patients in this group will be put under general anesthesia. At first, a fornix-based conjunctival flap is created. Then, a 4x 4 mm outer parabolic flap, approximately 200 μm thick will be dissected followed by an inner concentrically 2 x 2mm scleral flap sculpted beneath the previous one. The internal flap should be dissected deep enough to have a dark reflex from the underlying choroid. The subconjunctival bevacizumab (ScB) group receive of 1.25 mg/ 0.3 ml of bevacizumab, subconjuctival injection at the end of surgery, while the cut is advanced anteriorly, Schlemm’s canal is de-roofed. The two ostia of Schlemm’s canal are then cannulated with the specific 190 μm cannulaand Schlemm’s canal is dilated by slow and repeated injections of high-molecular-weight sodium hyaluronate . By gently pulling the inner scleral flap upwards and delicately depressing the floor of the canal and Descemet’s membrane with the tip of a cotton swab, the membrane itself is then cleaved from the cornea and the cleavage is advanced in clear cornea for approximately 1 mm, thus creating the so-called ‘trabeculo-descemetic window’ .As soon as the window is completed, the inner scleral flap is excised. The next step is the sealing of the lake, which is obtained by tightly suturing the outer scleral flap with seven 10-0 nylon stitches. High-molecular-weight sodium hyaluronate is then injected underneath the flap to fill the intrascleral space temporarily, preventing it from collapsing and scarring in the early post-operative period. Finally, the conjunctiva is sutured in place. Intraocular pressure. Timepoint: Before surgery, 1 day, 3 days, 2 weeks, 4 weeks, 3 months and 6 months after surgery. Method of measurement: Goldmann applanation tonometry (mmHg). Visual acuity. Timepoint: Before surgery, 1 day, 3 days, 2 weeks, 4 weeks, 3 months and 6 months after surgery. Method of measurement: Snellen charts. Visual field. Timepoint: Before surgery, 6 months after surgery. Method of measurement: Humphrey 24-2 SITA Standard perimetry (HFA 24-2) Or(HF30-2). Beleb morphology. Timepoint: Before surgery, 1 day, 3 days, 2 weeks, 4 weeks, 3 months and 6 months after surgery. Method of measurement: Moorfields Bleb Grading System. Endophthalmitis. Timepoint: Before surgery, 1 day, 3 days, 2 weeks, 4 weeks, 3 months and 6 months after surgery. Method of measurement: Examination slitlamp. Conjunctival necrosis. Timepoint: Before surgery, 1 day, 3 days, 2 weeks, 4 weeks, 3 months and 6 months after surgery. Method of measurement: Examination slitlamp. Vice Chancellor for research of Tabriz University of Medical Sciences Approved 2016-12-26 Office of the Vice Chancellor for Researchof Tabriz University of Medical Sciences International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz tabriz Iran (Islamic Republic of)