Abstract
BackgroundExcessive wound healing, with scarring of the episcleral tissue or encapsulation of the filtering bleb is the main reason for failure in trabeculectomy. Ranibizumab, an inhibitor of the Vascular Endothelial Growth Factor (VEGF), is seen as a promising candidate to prevent or treat extensive wound healing. We describe the design of a two phased study, i) assessing the local tolerability and safety of topical ranibizumab and ii) assessing the efficacy of topical ranibizumab against placebo in patients who underwent trabeculectomy with mitomycin C combined with phacoemulsification and intra ocular lens (IOL) implantation.Methods/DesignIn the first phase five patients that had trabeculectomy with mitomycin C combined with phacoemulsification and IOL implantation will be treated with topical ranibizumab (Lucentis®) eye drops (2 mg/ml) four times daily for one month. The treatment will be started at the first postoperative day. Patients will be assessed for local and systemic side effects using a standardised schedule. In the second phase, after successful completion of phase 1, consenting eligible patients who underwent trabeculectomy with mitomycin C combined with phacoemulsification and IOL implantation will be randomised to either receive topical ranibizumab eye drops (2 mg/ml) four times daily for 1 month or placebo (BSS 4x/d for 1 month). Patients will be reviewed weekly for 4 weeks until conjunctival sutures are removed. Further follow up examinations are planned after 3 and six months. Assessment of differences in the intraocular eye pressure will be considered primary, and bleb appearance/vascularisation using a standardized photography and the Moorfields bleb grading system, postoperative intraocular pressure and conjunctival wound healing problems will be considered secondary outcome parameters.DiscussionAnti-VEGF-antibodies might be more effective in preventing scaring and might have fewer toxic side effects than the currently used anti-metabolites and may replace them in the long term.Trial RegistrationISRCTN: ISRCTN12125882
Highlights
Excessive wound healing, with scarring of the episcleral tissue or encapsulation of the filtering bleb is the main reason for failure in trabeculectomy
Trabeculectomy is a surgical procedure for glaucoma, in which a guarded fistula is created
This fistula allows aqueous humour to drain from the anterior chamber to the subconjunctival space providing a controlled lowering of the intraocular pressure (IOP)
Summary
With scarring of the episcleral tissue or encapsulation of the filtering bleb is the main reason for failure in trabeculectomy. Trabeculectomy is a surgical procedure for glaucoma, in which a guarded fistula is created. This fistula allows aqueous humour to drain from the anterior chamber to the subconjunctival space providing a controlled lowering of the intraocular pressure (IOP). An increased wound healing response with scarring of the episcleral tissue or encapsulation of the filtering bleb is the main reason for failure of filtration surgery with consecutive loss of IOP control. To enhance the success rate of filtration surgery, wound healing modifying agents, such as 5-fluorouracil or mitomycin C (MMC) are widely used [2,3,4,5,6,7]. A T-lymphocyte mediated lysis of MMC treated Tenon’s capsule fibroblasts could be responsible for this problem [9]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
