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SL Seah, G Gazzard, ST Hoh, DT H Tan, F Oen; A Novel, Sustained-release Drug Delivery Device for Localised 'Beneath-the-flap' Steroids in Phaco-trabeculectomy . Invest. Ophthalmol. Vis. Sci. 2002;43(13):3346.
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Purpose: To assess the initial safety and tolerability of an intra-scleral slow-release steroid pellet - SurodexTM, (Oculex Pharmaceuticals Inc.) for combined phaco-trabeculectomy. Methods: Patients undergoing primary combined (separate site) phacoemulsification and trabeculectomy for primary glaucoma received a single sustained release dexamethasone pellet (SurodexTM) placed beneath the standard scleral flap at the end of surgery, in addition to topical steroid and antibiotic. Full ophthalmic examination was conducted at baseline and follow-up. Standard interventions of massage, laser suturelysis and bleb needling (+/- 5FU) were permitted if necessary. This initial 'in-principle' study was designed to evaluate safety and monitor pellet dissolution in vivo using ultrasound biomicroscopy (UBM). Out of 70 Asian subjects enrolled, 16 Chinese patients who have reached 2 months follow-up are presented here (mean 67.4 days, range 60-106). Mean age 65.0 years (44 - 83). Results: No significant complications, adverse drug reactions or surgical failures were seen during follow-up. 11 patients received posterior lip flap massage, 12 required suturelysis and 5 ultimately received bleb needling, with 4 receiving 5FU. Bleb morphology was diffuse and non-cystic, with no avascular areas. The intra-ocular pressure was significantly reduced from a baseline mean of 27.8 mm Hg (+/- 6.7 SD) to 15.8 mm Hg (+/- 5.0 SD) at last follow-up, p < 0.001 (paired T Test). Surodex pellets were visible on UBM as a high signal-density intra-scleral area with prominent shadowing. Complete dissolution of the pellet on UBM took up to 4 weeks. Conclusion: Localised sustained-release steroid delivery by a biodegradable spacer device appears to be a safe and simple means to deliver steroids to the intrascleral site. A separate randomised controlled trial will investigate the efficacy of long-term pressure control.
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