Glaucoma
Conditions
Keywords
Trabeculectomy, bevacizumab, intraocular pressure
Brief summary
The purpose of this study is to evaluate the adjunctive effect of intratenon Bevacizumab on the result of trabeculectomy in primary term of intraocular pressure (IOP).
Detailed description
Prospective interventional clinical trial Single center, outcome assessor-masked, active control, randomized controlled trial
Interventions
DRUGBevacizumab
Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
DRUGMitomycin C
Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
Sponsors
Prince of Songkla University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Primary open angle glaucoma with primary mmc-trabeculectomy indication
Exclusion criteria
* combined phacoemulsification with trabeculectomy * no more than 6 month of cataract surgery before trabeculectomy * revised trabeculectomy * active uveitic glaucoma * neovascular glaucoma * par planar vitrectomy * conjunctival surgery * allergy to bevacizumab or mitomycin C * ischemic heart disease * cerebrovascular disease * renal failure * liver failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure | 6 month |
Secondary
| Measure | Time frame |
|---|---|
| Bleb characteristic grading | 6 month |
| systemic Blood pressure | 6 months |
Countries
Thailand
Outcome results
None listed