Rassoul Akram hospital, eye research center
Tehran, Tehran Province, 14455-364, Iran
NCT Number: NCT01310764
The purpose of this study is to investigate the safety and efficacy of bevacizumab as an adjunctive treatment to trabeculectomy in open angle glaucoma patients and to compare this new drug to the most commonly used anti-scarring agent, mitomycin C.
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Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Tehran, Tehran Province, 14455-364, Iran
The most common surgical technique for controlling the intraocular pressure in glaucoma patients is trabeculectomy.In this surgery, internal cavity of the eye is connected by a fistula like openings to subconjunctival space. The main cause of failure in trabeculectomy is excessive postoperative conjunctival scarring at the site of fistula, which is related to severity of conjunctival vascularization, tortuousity of vessel, and fibroblast migration and proliferation. At the time of surgery most surgeons use mitomycin C, which is an antimitotic and antifibrotic agent, to improve the results of the procedure. Although this agent is very effective, but is not without complication. The most significant and sight threatening complications are low intraocular pressure and endophthalmitis. Therefore investigations are going on to find a much safer and effective agents. Bevacizumab is a monoclonal antibody against vascular endothelial factor (VEGF). VEGF is an important vasculogenic and fibrogenic factor with a prominent role in wound healing.Bevacizumab is widely used in ophthalmology and has a promising effect in treatment of neovascularization in conjunctiva, cornea and retina. There are limited animal and human case series regarding the effect of this agent in trabeculectomy. In this study the investigators are trying, in addition to evaluating the efficacy and safety of this agent in result of trabeculectomy, compare this agent with mitomycin C.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery.
Time frame: 7-12 months
Pre and post operative intraocular pressures are measured with Goldmann applanation tonometer at each time point visits and the measurement were compared between both groups.
Time frame: 7-12 months
Number of pre and post operative medications were recorded and compared in each post operative visits.
Rassoul Akram Hospital
Other
Efficacy and Safety of Trabeculectomy With Subconjunctival Bevacizumab Versus Trabeculectomy With Mitomycin C.
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