Primary Open Angle Glaucoma (POAG) patients.
Conditions
Interventions
Methods
This randomized, prospective study will follow the tenets of the Declaration of Helsinki and will be previously approved by the medical review board committee of the Department of Ophthalmolog
were diagnosed with normal tension glaucoma, angle closure glaucoma or secondary glaucomas
had prior history of ocular infection, uveitis or ocular trauma
were pregnant or breast-feeding women
had a history of uncontrolled diabetes and/or systemic hypertension or any other systemic condition that could be influenced by BZM injections.
Only one auth
H40.1
Sponsors
União Metropolitana de Educação e Cultura
União Metropolitana de Educação e Cultura
Eligibility
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: The inclusion criteria will be: Primary Open Angle patients over 40 years of age, with uncontrolled Intraocular pressure (IOP) on maximum tolerated medical therapy, requiring trabeculectomy. Indications for trabeculectomy will include eyes where IOP measurements associated with a high probability of glaucoma progression or eyes where a deterioration of the visual field or the optic disk compatible with progressive glaucomatous damage was documented by the examining physician.
Exclusion criteria
Exclusion criteria: Patients will be excluded if known to have an allergic reaction either to MMC or BZM, had undergone previous intraocular surgery (except uneventful cataract surgery); were diagnosed with normal tension glaucoma, angle closure glaucoma or secondary glaucomas; had prior history of ocular infection, uveitis or ocular trauma; were pregnant or breast-feeding women; had a history of uncontrolled diabetes and/or systemic hypertension or any other systemic condition that could be influenced by BZM injections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure: mean intra-ocular pressure at baseline and 1-month, 3-month, 6-months and 12-months follow-up measured with Goldmann applanation tonometer (in mmHg). Intra-ocular pressure reduction above 20% from baseline will be considered clinically significant, in accordance with previous published literature. Differences > 3mmHg between group Bevacizumab and Mytomicin-C will be considered significant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleb morphology created after trabeculectomy surgery will be analyzed according to Moorfields Bleb Grading System, that grades bleb height, vascularity and area characteristics. Differences in bleb shape, area and vascularização between Bevacizumab and Mytomicin-C group will be evaluated at final follow-up of studied patients. | — |
Countries
Brazil
Contacts
Public ContactRoberto Pimentel
RR/UNIVISÃO
Outcome results
None listed