Efficacy and Safety of the ExPRESS Glaucoma MiniShunt

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Efficacy and Safety of the Ex-PRESS Glaucoma Mini-Shunt with Intraoperative 5 -Fluorouracil ASCRS 2009

Efficacy and Safety of the Ex-PRESS Glaucoma Mini-Shunt with Intraoperative 5 -Fluorouracil ASCRS 2009 – San Francisco A. Balashanmugam, MD, L. Farrokh-Siar, MD, University Eye Specialists Chicago, IL Authors have no financial interest

Introduction Ø The Ex-PRESSTM glaucoma mini-shunt was designed for implantation under a partial-thickness scleral

Introduction Ø The Ex-PRESSTM glaucoma mini-shunt was designed for implantation under a partial-thickness scleral flap for patients with open angle glaucoma. Ø In a prior study, the Ex-PRESS was found to have comparable efficacy, with a lower rate of hypotony, in comparison to trabeculectomy (1). Ø A recent case series of Ex-PRESS followed for 3 years reported a high rate of success and a low rate of complication (2). 1. P. J. G. Maris, K Ishida, P A Netland. Comparison of Trabeculectomy with Ex-PRESS Miniature Glaucoma Device Implanted Under Scleral Flap. J Glaucoma. 2007 Jan; 16: 14 -19. 2. E. Kanner, P. A Netland, S. R Sarkisian, H. Du. Ex-PRESS Miniature Glaucoma Device Implanted Under a Scleral Flap Alone or Combined With Phacoemulsification Cataract Surgery. J. Glaucoma Feb 2009 (Epub ahead of print)

Introduction Ø The use of antimetabolites has greatly increased success rates of glaucoma filtering

Introduction Ø The use of antimetabolites has greatly increased success rates of glaucoma filtering surgery. Ø 5 -Fluorouracil (5 -FU) was introduced in 1984 and has been gaining popularity in clinical use (1). Ø Both of the studies listed previously have looked at the outcome of the Ex-PRESS mini-shunt in conjunction with the use of intraoperative Mitomycin C. 5 -Fluorouracil 1)D. Wudunn, L. B Cantor. A Prospective Randomized Trial Comparing Intraoperative 5 -Fluorouracil vs Mitomycin C in Primary Trabeculectomy. Am J Ophthalmol 2002; 134: 521– 528.

Purpose To report the efficacy and safety of the Ex-PRESS glaucoma mini-shunt implantation under

Purpose To report the efficacy and safety of the Ex-PRESS glaucoma mini-shunt implantation under a partial thickness scleral flap, using intraoperative and supplemental postoperative 5 -FU, in a population of African American patients with medically uncontrolled glaucoma. Ø Post-operative 5 FU injections 5 -Fluorouracil

Patient Demographics Ø Ø Ø N= 14 eyes (11 patients) Age: 71 ± 9.

Patient Demographics Ø Ø Ø N= 14 eyes (11 patients) Age: 71 ± 9. 8 (range 46 -81) years Gender: l l Ø Race : l Ø African American – 11/11 Lens Status: l l Ø Male – 6 (55 %) Female – 5 (45%) Phakic -12 (86%) Pseudophakic – 2 (14%) Glaucoma type: OAG – 12 (86%) l ACG -- 1 (7%) l Traumatic glaucoma – 1 (7%) Ø Follow-up: 9. 1 ± 4. 9 (range 1 -18) months l

Methods All eyes underwent Ex-PRESS implantation under a partial -thickness scleral flap with intraoperative

Methods All eyes underwent Ex-PRESS implantation under a partial -thickness scleral flap with intraoperative 5 -FU (50 mg/ml for 3 min). Ø Postoperative 5 -FU injections were given as required. Ø All surgeries were performed by a single surgeon (LFS). Ø Ex-PRESS under scleral flap Intraoperative 5 -FU Post-op 5 FU injections

Device Description Ø Stainless steel miniature glaucoma device with good biocompatibility(1) Ø Device length

Device Description Ø Stainless steel miniature glaucoma device with good biocompatibility(1) Ø Device length – 2. 64 mm Ø External lumen size - 400µm Ø Internal lumen size – 50µm Ex-PRESS P model specifications 1. A Nyska, Y. Glovinsky, M. Belkin, and Y. Epstein. Biocompatibility of the Ex-PRESS miniature glaucoma drainage implant. J Glaucoma. 2003 Jun; 12(3): 275 -80.

Results Outcomes measures: Ø IOP Ø Medications Ø Complications Ex-PRESS: Day 1 post –op

Results Outcomes measures: Ø IOP Ø Medications Ø Complications Ex-PRESS: Day 1 post –op Patients received an average of 3. 8 ± 3. 0 (range 1 -13) postoperative 5 -FU injections (0. 1 ml of 50 mg/ml).

Results - IOP Mean IOP: Ø Decreased from 33. 6 ± 9. 4 mm.

Results - IOP Mean IOP: Ø Decreased from 33. 6 ± 9. 4 mm. Hg to 13. 3 ± 3. 7 mm. Hg at last visit (p=0. 0002).

Results – Medication Need Mean # of anti-glaucoma meds: Ø Decreased from 4. 4

Results – Medication Need Mean # of anti-glaucoma meds: Ø Decreased from 4. 4 ± 0. 6 to 0. 4 ± 1. 1 at the last visit (p=0. 000).

Complications Choroidal effusion – 2 (14. 3%) Ø Flat AC – 1 (7. 1

Complications Choroidal effusion – 2 (14. 3%) Ø Flat AC – 1 (7. 1 %) Ø Surgical revision - 2 (14. 3%) Ø Ø No erosion or blockage of shunt, endophthalmitis or corneal decompensation observed

Conclusion Ø Implantation of the Ex-PRESSTM glaucoma mini-shunt with intraoperative (and supplemental postoperative) 5

Conclusion Ø Implantation of the Ex-PRESSTM glaucoma mini-shunt with intraoperative (and supplemental postoperative) 5 FU was effective in lowering IOP in this series of African American patients with uncontrolled glaucoma. A relatively low rate of complications was noted in this case series. Ø The use of 5 -FU provides a safe alternative to Mitomycin C, and should be considered for antifibrotic use in Ex. PRESS implantation.