Bleb Fibrosis, Bleb Vascularity, Trabeculectomy Failure
Conditions
Keywords
bevacizumab, subconjunctival injection, trabeculectomy, bleb, mitomycin c
Brief summary
Trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out. A rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. This leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study intends to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure.
Detailed description
trabeculectomy is an ocular surgery intended to reduce intra-ocular pressure the surgery creates a sub-conjunctival filtering bleb which filters aqueous humor fluid out. a rather common adverse event of the surgery is increasing vascularity of the conjunctiva overlying the bleb. this leads to adherence of the conjunctiva to the sclera and fibrosis and finally failure of the bleb (and of the surgery) this study wishes to demonstrate that post operative subconjunctival bevacizumab injection will reduce incidence of bleb vascularity and ultimately, bleb failure. during the study, one study group will be given subconjunctival bevacizumab 1 week after surgery, another study group will be given subconjunctival bevacizumab 2 week after surgery, and a third group will serve as control and will not receive bevacizumab. if bleb vascularity will be diagnosed all patients will be treated according to current guidelines.
Interventions
sub-conjunctival injection of 1.25mg Bevacizumab
Sponsors
Study design
Eligibility
Inclusion criteria
* post uneventful trabeculectomy with mitomycin c application during surgery * adult
Exclusion criteria
* usage of 5-fluorouracil in trabeculectomy * post-operative complications * ischemic heart disease * s/p cerebrovascular accident * allergy to bevacizumab
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleb vascularity grading | 1, 2, 3, 4, 5. 6. montes post operative. |
Secondary
| Measure | Time frame |
|---|---|
| Indiana Bleb Appearance Grading Scale (IBAGS) | 1, 2, 3, 4, 5, 6 months post operative |
| Intra-ocular pressure | 1, 2, 3, 4, 5, 6 months post operative |
| Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no | 1, 2, 3, 4, 5, 6 months post operative |
Countries
Israel