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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.

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efficacy and safety of the ex press glaucoma mini shunt with intraoperative 5 fluorouracil

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
Introduction
  • The Ex-PRESSTM 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).
  • 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.
  • 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)
introduction3
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.

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
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

patient demographics
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
methods
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-FU

Post-op 5FU injections

device description
Device Description
  • Stainless steel miniature glaucoma device with good biocompatibility(1)
  • Device length – 2.64mm
  • External lumen size - 400µm
  • 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
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

results iop
Results - IOP

Mean IOP:

  • Decreased from 33.6 ± 9.4mmHg to 13.3 ± 3.7 mmHg at last visit (p=0.0002).
results medication need
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).
complications
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
conclusion
Conclusion
  • 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.
  • The use of 5-FU provides a safe alternative to Mitomycin C, and should be considered for antifibrotic use in Ex-PRESS implantation.