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Sunita Radhakrishnan, M.D Glaucoma Center of San Francisco

Glaucoma Research and Education Group

Ophthalmologic shunts

ExPRESS shunt Aqueous shunts

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Ex-PRESS™ shunt

•  Originally designed to be implanted under the conjunctiva

•  High incidence of complications – Early hypotony (90% in one series) – Suprachoroidal hemorrhage

Wamsley, Moster et al, AJO 2004

Arch Ophthalmol Sep 2005

AJO, Aug 2005

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J Glaucoma 2005;14,98-102

ExPRESS™ Shunt

UC USF

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External plate Spur

Transverse port

Bevelled tip

Ex-PRESS™ shunt

Stainless steel Non-magnetic

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ExPRESS™ Shunt R-50 Model

External lumen 400µm

Internal lumen size 50µm

Device length 2.96 mm

Pre-incision needle 27G

Ex-PRESS™ shunt – P 50 model

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Ophthalmic Surg Lasers Imaging, Sep/Oct 2007

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ExPRESS™ shunt USF

•  Is it effective in lowering IOP? •  Is it safe? •  Are there any advantages over

trabeculectomy?

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Intermediate to Long term data

•  Non-randomized retrospective series •  Up to 4 year follow up

Intermediate term results – Study #1

Ex-PRESS Ex-PRESS/Phaco

Number of eyes 231 114

Mean follow up 26 ± 11 months 22 ± 13 months

IOP @ 36 months 16.4 ± 4.1 16.8 ± 5.1

Success @ 36 months 94.8% 95.6%

Kanner,Netland et al. Journal of Glaucoma, August 2009

Success – IOP 5-21 with or without meds, no further surgery (except needling), no device removal

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Intermediate term results – Study #2

•  100 eyes of 100 patients with Ex-PRESS implantation •  All eyes had prior surgery

–  50% phaco, 43% trab, 5% combined phaco/trab •  Follow up: 27 ± 13 months (range 12-66 months) •  Mean post-operative IOP of 14.5 ± 6.5 mm Hg •  Probability of success at 3 years

–  61% in eyes with previous cataract surgery –  51% in eyes with prior trabeculectomy

Lankaranian, Moster et al. Clin Experiment Ophthalmol July 2011

Long term results – Study # 3

•  97 eyes of 72 patients with OAG –  39% with prior glaucoma surgery

•  Ex-PRESS or Ex-PRESS/Phaco (34%) •  Success (IOP ≤ 18 with/without meds)

–  90%, 83%, 73% @ 2, 3, 4 years

Ben-Hur and Dahan, ARVO 2008 Poster

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Ben-Hur and Dahan, ARVO 2008 Poster

Long term results

•  Netland series –  6 eyes had ‘tube blockage’ treated with Nd-Yag laser

•  Lankarianian series –  Hyphema (1), high IOP (16), conjunctival resuturing (3),

choroidal drainage (1)

•  Dahan series –  12 eyes (12%) required further surgery

•  Device exchange, Flap revision, Cataract extraction

•  Other case reports –  Device exposure, blebitis

Ex-PRESS USF: Complications

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Ex-PRESS versus Trabeculectomy

•  Retrospective comparative series •  50 eyes in each group •  Success definition

–  IOP 5-21 with/without glaucoma meds, no further surgery (except needling) or removal of implant

•  Early hypotony: IOP < 5 during 1st week •  Avg follow up 10.8 mths (3.5 to 18 months)

Maris, Ishida, Netland - J Glaucoma, 2007

Ex-PRESS Trabeculectomy Number of eyes 50 50

Mean follow up 10.8 months 11.2 months

Success at 15 months 86% 84%

IOP < 5 in first week 4% 32%

Choroidal drainage 1 eye (2%) 5 eyes (10%)

Bleb needling 10 eyes (20%) 7 eyes (14%)

Ex-PRESS versus Trabeculectomy

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ExPRESS vs Trab

Ex-PRESS versus Trabeculectomy

•  Retrospective consecutive case control series •  35 eyes in each group •  Success definition

–  IOP 5-18 AND at least 30% decrease in IOP without glaucoma meds

•  Avg follow up 28 mths

Good and Kahook - AJO, March 2011

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Ex-PRESS Trabeculectomy Number of eyes 35 35

Success at final f/u 77% 74%

No. of post-op visits 6.0 ± 0.5 8.2 ± 0.9

Recovery of near baseline visual acuity 1 week 1 month

Ex-PRESS versus Trabeculectomy

ExPRESS vs Trabeculectomy

•  Bleb morphology based on Moorfield’s grading system – No difference in bleb height, vascularity or extent at

final follow-up – Upto 18 months – ExPRESS blebs were higher, less

vascular and more diffuse •  Complications

– No difference between groups

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Ex-PRESS – Pros

•  No iridectomy/sclerectomy necessary – Fast – Less inflammation

•  Anterior chamber stability •  ?Less hypotony •  ?More diffuse posterior blebs

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Ex-PRESS - Cons

•  No prospective data showing superiority over trabeculectomy

•  Unknown long-term device-related complications

•  Additional cost of device

Randomized controlled studies

•  DeJong et al, Netherlands – ExPRESS versus Trab WITHOUT mitomycin-C –  5 year success rate without medications

•  59% ExPRESS, 46% Trab (p=0.25)

– From 1-3 years follow-up, more Ex-PRESS eyes achieved IOP < 15 without medications

•  XVT – Results not released

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Ex-PRESS shunt

•  Patients on anticoagulation •  Unknown bag/zonule status

– Complicated cataract surgery – Exfoliation syndrome

•  Uveitis

Ex-PRESS shunt

•  Informed consent •  Adequate scleral flap size and thickness •  Viscoelastic in AC prior to shunt insertion is

helpful •  Irrigate viscoelastic at the end of procedure •  Digital massage relatively less effective than after

trabeculectomy

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Conclusions

•  Promising device •  More data required to clarify its position in the

management algorithm