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

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-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).

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 1614-19.
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)

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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 2002134 521528.
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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
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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

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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
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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.
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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
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Results - IOP

• Mean IOP
• Decreased from 33.6 9.4mmHg to 13.3 3.7 mmHg
  at last visit (p0.0002).

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Results Medication Need

• Mean of anti-glaucoma meds
• Decreased from 4.4 0.6 to 0.4 1.1 at the last
  visit (p0.000).

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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

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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.