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-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.

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)

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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 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

      

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

   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)  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 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 ± at last visit (p=0.0002).

9.4mmHg to 13.3 ± 3.7 mmHg

IOP Dynamics

40 30 20 10 0 0 1 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 (p=0.000).

± 0.6 to 0.4 ± 1.1 at the last visit

Medications Dynamics

3.0

2.5

2.0

1.5

1.0

0.5

0.0

0 1 2 3 4 5 6 7

Time (Months)

8 9 10 11 12 13

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

 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.