Transcript Efficacy and Safety of the Ex-PRESS Glaucoma Mini

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

The Ex-PRESSTM glaucoma mini-shunt was designed
for implantation under a partial-thickness scleral flap
for patients with open angle glaucoma.
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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)
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
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

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N= 14 eyes (11 patients)
Age: 71 ± 9.8 (range 46-81) years
Gender:



Race :

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African American – 11/11
Lens Status:

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Male – 6 (55 %)
Female – 5 (45%)
Phakic -12 (86%)
Pseudophakic – 2 (14%)
Glaucoma type:
OAG – 12 (86%)
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ACG -- 1 (7%)

Traumatic glaucoma – 1 (7%)
 Follow-up: 9.1 ± 4.9 (range 1-18) months
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Methods
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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

Stainless steel miniature glaucoma
device with good biocompatibility(1)
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Device length – 2.64mm

External lumen size - 400µm
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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:
 IOP
 Medications
 Complications
Ex-PRESS: Day 1 post –op
Patients received an average of 3.8 ± 3.0 (range 1-13)
postoperative 5-FU injections (0.1ml of 50mg/ml).
Results - IOP
Mean IOP:
 Decreased from 33.6 ± 9.4mmHg to 13.3 ± 3.7 mmHg
at last visit (p=0.0002).
IOP Dynamics
IOP (mmHg)
40
30
20
10
0
0 1
Pre-11d 1w
2
3
4
5
6
7
Time (Months)
8
9
10 11 12 13
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).
Medications Dynamics
3.0
No. of Med
2.5
2.0
1.5
1.0
0.5
0.0
Pre
-1 1d01w 1
2
3
4
5
6
7
Time (Months)
8
9
10
11
12
13
Complications
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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

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.