None listed
Conditions
Brief summary
The aim of the study is to evaluate the impact of the intravitreal bevacizumab injection on the Ahmed valve implant surgical outcome on neovascular glaucoma patients without clinical control. The design is a prospective, randomized, clinical trial with 35 individuals. Those individuals who need a drainage implant surgery to control the intraocular pressure (IOP), will be randomized for intravitreal 1.0 mg bevacizumab injection (0.04 mL of the commercial bevacizumad solution with a concentration of 25 mg/mL) or 0.5 mL of balanced salt solution. “Surgical Success” will be defined as the following criteria: (1) postoperative IOP equal or less than 21 mmHg; or (2) 30% IOP reduction or more after the surgery, with or without glaucoma medication. Any other situation will be considered surgical failure. Statistical analysis will be performed with the chi-square and t Student’s tests, the success rates will be compared with Kaplan-Meier curve and the log rank test.
Interventions
The surgical procedure will consist of a 1-stage Ahmed Glaucoma Valve implantation using a standardized surgical technique. After administration of regional or general anesthesia, a fornix based conjunctival flap will be fashioned in the superotemporal quadrant. The anterior edge of the plate will be secured with 9-0 nylon sutures to the sclera at least 8 mm from the limbus. The tube tip will be cut obliquely to protect the tube lumen from the iris. A 23-gauge needle tract will be used to enter
The surgical procedure will consist of a 1-stage Ahmed Glaucoma Valve implantation using a standardized surgical technique. After administration of regional or general anesthesia, a fornix based conjunctival flap will be fashioned in the superotemporal quadrant. The anterior edge of the plate will be secured with 9-0 nylon sutures to the sclera at least 8 mm from the limbus. The tube tip will be cut obliquely to protect the tube lumen from the iris. A 23-gauge needle tract will be used to enter the anterior chamber through the limbus. The tube in the anterior chamber will be positioned anterior to the iris and away from the corneal endothelium. A donor sclera or a human pericardium patch graft will be fashioned from banked tissue and secured with interrupted 10-0 nylon sutures over the exposed portion of the tube. Conjunctiva will be sutured either with 8-0 or 9-0 polyglactin sutures or with 10-0 nylon sutures. The anterior chamber will be reformed with BSS through a paracentesis tract. Viscoelastic material will be injected into the anterior chamber at the surgeon’s discretion. At the end of surgery approximately 1.25 mg of bevacizumab (0.05 mL of commercially available bevacizumab at a concentration of 25 mg/mL) or 0.05 mL of sterille saline salt solution will be injected into the eye via pars plana with a 1.00-mL syringe attached to a 30-gauge needle. The postoperative regimen will include a topical antibiotic and a cycloplegic for 2 to 4 weeks, and topical steroids for approximately 2 months. Antiglaucoma medication will be added as required to improve IOP reduction. Patients will be examined 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 12 months, and 18 months after surgery.
Sponsors
Dr. Enyr Saran Arcieri
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
All patients with uncontrolled neovascular glaucoma that underwent prior pan retinal photocoagulation requiring glaucoma drainage device implantation will be eligible.
Exclusion criteria
Patients younger than 18 years; with learning difficulties, mental illness, or dementia; unconscious; or severely ill will not be included in the study.
Outcome results
None listed