1. 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

2. Introduction   The Ex-PRESS TM glaucoma mini-shunt was designed for implantation under a partial-thickness scleral flap for patients with open angle glaucoma.   In a prior study, the Ex-PRESS was found to have comparable efficacy, with a lower rate of hypotony, in comparison to trabeculectomy (1).   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)

3. Introduction   The use of antimetabolites has greatly increased success rates of glaucoma filtering surgery.   5-Fluorouracil (5-FU) was introduced in 1984 and has been gaining popularity in clinical use (1).   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. 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. 5-Fluorouracil

4. 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. Post-operative 5FU injections 5-Fluorouracil

5. Patient Demographics   N = 14 eyes (11 patients)   Age : 71 ± 9.8 (range 46-81) years   Gender : Male – 6 (55 %) Female – 5 (45%)   Race : African American – 11/11   Lens Status: Phakic -12 (86%) Pseudophakic – 2 (14%)   Glaucoma type : OAG – 12 (86%) ACG -- 1 (7%) Traumatic glaucoma – 1 (7%)   Follow-up : 9.1 ± 4.9 (range 1-18) months

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

7.   Stainless steel miniature glaucoma device with good biocompatibility (1)   Device length – 2.64mm   External lumen size - 400µm   Internal lumen size – 50µm Device Description 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. Ex-PRESS P model specifications

8. Results Outcomes measures:   IOP   Medications   Complications Patients received an average of 3.8 ± 3.0 (range 1-13) postoperative 5-FU injections (0.1ml of 50mg/ml). Ex-PRESS: Day 1 post –op

9. Results - IOP Mean IOP:   Decreased from 33.6 ± 9.4mmHg to 13.3 ± 3.7 mmHg at last visit (p=0.0002).

10. Results – Medication Need Mean # of anti-glaucoma meds:   Decreased from 4.4 ± 0.6 to 0.4 ± 1.1 at the last visit (p=0.000).

11. Complications   Choroidal effusion – 2 (14.3%)   Flat AC – 1 (7.1 %)   Surgical revision - 2 (14.3%)   No erosion or blockage of shunt, endophthalmitis or corneal decompensation observed

12. Conclusion   Implantation of the Ex-PRESS TM 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.   The use of 5-FU provides a safe alternative to Mitomycin C, and should be considered for antifibrotic use in Ex-PRESS implantation.