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IRCT2014102219206N3 IRCT 2014-11-08 vice chancellor of research,Iran University of Medical Sciences Trabeculectomy with versus without intravitreal bevacizumab in diabetic patients Trabeculectomy with versus without intravitreal bevacizumab in diabetic patients 2014-10-01 anticipated 52 Complete https://irct.ir/trial/17240 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Glaucoma. Intervention 1: All surgeries are carried outby a single experienced surgeon(N.Ni.). For all eyes, after creating the scleral flap, MMC 0.02%(0.2mg/mL)isapplied using multiple thin sponges under the scleral flap between the sclera and Tenon capsule for 2 minutes. At the end of surgery, the conjunctiva is closed with10-0 nylonsutures. In the bevacizumab group after suturing the conjunctiva , 2.5mg (0.1mL)bevacizumab (Avastin) is injected intravitreally. Intervention 2: In the same fashion, trabeculectomy is performed in the control group, but without intravireal bevacizumab injection.
public Acieh Eshaghi
Eye Research Center,Rassoul Akram Hospital
Tehran Iran (Islamic Republic of) +98 21 6650 9162 acieh_eshaghi@yahoo.com Eye Research Center,Rassoul Akram Hospital scientific Naveed Nilforoushan
Eye Research Center, Rassoul Akram Hospital
Tehran Iran (Islamic Republic of) +98 21 6650 9162 naveednil@yahoo.com Eye Research Center, Rassoul Akram Hospital,Iran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: diabetic patients who are candidate for trabeculectomy(inadequately controlled glaucoma with maximally tolerated medical therapy or intolerance to antiglaucoma medications). Exclusion criteria: being pregnant or currently breast feeding; past history of any ocular surgery other than cataract surgery in more than 6 months before trabeculectomy; ocular surface infection over the previous 2 weeks; systemic thromboembolic events; neovascular glaucoma; concurrent cataract surgery; age younger than 18 years old; diabetic retinopathy which needs lasertherapy or intravitreal injection of anti- VEGF over the previous 6 months or within 6 months after trabeculectomy. 18 years no limit Both H40 Glaucoma Treatment - Drugs N/A All surgeries are carried outby a single experienced surgeon(N.Ni.). For all eyes, after creating the scleral flap, MMC 0.02%(0.2mg/mL)isapplied using multiple thin sponges under the scleral flap between the sclera and Tenon capsule for 2 minutes. At the end of surgery, the conjunctiva is closed with10-0 nylonsutures. In the bevacizumab group after suturing the conjunctiva , 2.5mg (0.1mL)bevacizumab (Avastin) is injected intravitreally. In the same fashion, trabeculectomy is performed in the control group, but without intravireal bevacizumab injection. Intra Ocular Pressure. Timepoint: Days1, 7, 14, 30, 60, 90 and 180 after trabeculectomy. Method of measurement: IOP measurement by Goldmann tonometry. Rate of qualified sugical success. Timepoint: Days 1, 7, 14, 30, 60, 90 and 180 after trabeculectomy. Method of measurement: qualified success is IOP of 21mmHg or less and at least 20% reduction in the preoperative IOP with antiglaucoma medications where the number ofthem is less than that used before surgery. BCVA. Timepoint: Days 1, 7, 14, 30, 60, 90 and 180 after trabeculectomy. Method of measurement: The BCVA is measured by Snellen chart. Number of antiglaucoma medications. Timepoint: Days 1, 7, 14, 30, 60, 90 and 180 after trabeculectomy. Method of measurement: number of drugs to control the IOP. Rate of complete surgical success. Timepoint: Days 1, 7, 14, 30, 60, 90 and 180 after trabeculectomy. Method of measurement: Complete surgical success is defined by IOP of 21mmHg or less and at least20 % reduction in the preoperative pressure without any antiglaucoma medications. Bleb evaluation results. Timepoint: months 1 and 6. Method of measurement: Bleb photographs are obtained at months 1 and at the last follow-up.Bleb photographs at the last follow-up are graded by a masked glaucoma specialist(N.Ni.) who compares the study photographs with standard photographs , according to the Indiana Bleb Appearance Grading Scale ,which is based on extension,height,vascularization, and leakage. vice chancellor of research,Iran University of Medical Sciences Approved 2014-10-01 ethics committee of Iran University of Medical Sciences Iran,Tehran,Iran University of Medical Sciences Tehran Iran (Islamic Republic of)