Glaucoma. Glaucoma
Conditions
Interventions
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
Treatment - Drugs
In the same fashion, trabeculectomy is performed in the control group, but without intravireal bevacizumab injection.
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 bet
Sponsors
vice chancellor of research,Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intra Ocular Pressure. Timepoint: Days1, 7, 14, 30, 60, 90 and 180 after trabeculectomy. Method of measurement: IOP measurement by Goldmann tonometry. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAcieh Eshaghi
Eye Research Center,Rassoul Akram Hospital
Outcome results
None listed