Primary open-angle glaucoma. Glaucoma (primary)(residual stage): capsular with pseudoexfoliation of lens, chronic simple, low-tension, pigmentary
Conditions
Interventions
Intervention 1: Intervention 1: single injection of 1.25 mg (0.05 ml
concentration 25 mg/ml) bevacizumab (monoclonal antibody against VEGF
trade name Avastin, Genentech/Roche, San Francisco, CA) in the anterior chamber at termination of trabeculectomy surgery. Intervention 2: Intervention 2: single injection of placebo (0.05 ml balanced
Treatment - Drugs
Placebo
Intervention 1: single injection of 1.25 mg (0.05 ml
trade name Avastin, Genentech/Roche, San Francisco, CA) in the anterior chamber at termination of trabeculectomy surgery
Intervention 2: single injection of placebo (0.05 ml balanced salt solution) in the anterior chamber at termination of trabeculectomy surgery
Sponsors
Vice chancellor for research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Primary open angle or pseudoexfoliative glaucoma patients 65 years or older who are candidates of standard trabeculectomy procedure (whose optic nerve function is failing or is likely to fail and is already on the maximum tolerated medical therapy and not likely to achieve a sufficient lOP reduction with laser treatment). Exclusion criteria: Patients at high risk of failure of trabeculectomy, including aphakic, pseudophakic, uveitic, neovascular and juvenile glaucoma.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success of trabeculectomy. Timepoint: six months after surgery. Method of measurement: Goldmann applanation tonometry (intraocular pressure between 6 and 21 ml Hg and 30% reduction of intraocular pressure compared to preoperative values). | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular pressure. Timepoint: Before and 1 day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery. Method of measurement: Goldmann applanation tonometry.;Corrected distance visual acuity. Timepoint: Before and 1 day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery. Method of measurement: clinical examination.;Morphology of filtration Bleb. Timepoint: one day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery. Method of measurement: Slit lamp exam; Moorfields bleb grading system and Indiana bleb appearance grading scale.;Number of medications used to lower the intraocular pressure. Timepoint: Before and 1 day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery. Method of measurement: History.;Complications of intervention including bleb leak, encapsulation and need to globe massage. Timepoint: one day, 7 days, 14 days, 1 month, 3 months and 6 months following surgery. Method of measurement: clinical examination.;Visual field. Timepoint: Before and 6 months after surgery. Method of measurement: perimetry.;Optic nerve head appearance and cup to disc ratio. Timepoint: Before and 6 months after surgery. Method of measurement: slit lamp exam and OCT of optic nerve head.;Status of nerve fiber layer. Timepoint: Before and 6 months after surgery. Method of measurement: GDX and OCT of nerve fiber layer. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHadi Ghadimi
Farabi Eye Hospital
Outcome results
None listed