Clinical Trial: Subconjunctival Bevacizumab Effect on Bleb Vascularity
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Subconjunctival Bevacizumab Injection for the Prevention of Bleb Vascularization Post Trabeculectomy
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 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 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.
Sponsor: Rabin Medical Center
Current Primary Outcome: Bleb vascularity grading [ Time Frame: 1, 2, 3, 4, 5. 6. montes post operative. ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Indiana Bleb Appearance Grading Scale (IBAGS) [ Time Frame: 1, 2, 3, 4, 5, 6 months post operative ]
- Intra-ocular pressure [ Time Frame: 1, 2, 3, 4, 5, 6 months post operative ]
- Indication for subconjunctival Mitomycin C injection or revision of surgery = yes / no [ Time Frame: 1, 2, 3, 4, 5, 6 months post operative ]
Original Secondary Outcome: Same as current
Information By: Rabin Medical Center
Dates:
Date Received: March 1, 2009
Date Started: April 2009
Date Completion: October 2011
Last Updated: March 2, 2009
Last Verified: February 2009
