July 2018
Volume 59, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2018
12-month interim results of a multicentre open-label study of the InnFocus MicroShunt® Glaucoma Drainage System in patients with primary open-angle glaucoma
Author Affiliations & Notes
  • Tarek M Shaarawy
    Hôpitaux Universitaires de Genève, Geneva, Switzerland
  • Florent Aptel
    CHU de Grenoble, Grenoble, France
  • Henny J Beckers
    Maastricht University Clinic for Ophthalmology, Maastricht, Netherlands
  • Carroll A B Webers
    Maastricht University Clinic for Ophthalmology, Maastricht, Netherlands
  • Elisa Bluwol
    Hôpital Paris Saint Joseph, Paris, France
  • José M Martínez-de-la-Casa
    Hospital Universitario Clínico San Carlos, Madrid, Spain
  • Julián García-Feijoó
    Hospital Universitario Clínico San Carlos, Madrid, Spain
  • Yves Lachkar
    Hôpital Paris Saint Joseph, Paris, France
  • Carmen D. Méndez-Hernández
    Hospital Universitario Clínico San Carlos, Madrid, Spain
  • Isabelle Riss
    Pôle Ophthalmologique de la Clinique Mutualiste, Bordeaux, France
  • Footnotes
    Commercial Relationships   Tarek Shaarawy, InnFocus Inc. (F), Santen Inc. (R); Florent Aptel, Alcon (R), Allergan (R), Novartis (R), Thea (R); Henny Beckers, Alcon (F), Alcon (R), Glaukos (F), Santen (F), Santen (R); Carroll Webers, None; Elisa Bluwol, None; José Martínez-de-la-Casa, Allergan (R), Glaukos (R), Ivantis (F), Santen (F), Santen (R); Julián García-Feijoó, Alcon (F), Alcon (R), Allergan (F), Esteve (R), Glaukos (F), IStaar (R), Ivantis (F), Novartis (F), Pfizer (F), Santen (F), Santen (R); Yves Lachkar, None; Carmen Méndez-Hernández, None; Isabelle Riss, None
  • Footnotes
    Support  Sponsored by InnFocus, a Santen company
Investigative Ophthalmology & Visual Science July 2018, Vol.59, 3457. doi:
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      Tarek M Shaarawy, Florent Aptel, Henny J Beckers, Carroll A B Webers, Elisa Bluwol, José M Martínez-de-la-Casa, Julián García-Feijoó, Yves Lachkar, Carmen D. Méndez-Hernández, Isabelle Riss; 12-month interim results of a multicentre open-label study of the InnFocus MicroShunt® Glaucoma Drainage System in patients with primary open-angle glaucoma. Invest. Ophthalmol. Vis. Sci. 2018;59(9):3457.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The InnFocus MicroShunt® Glaucoma Drainage System (MicroShunt) (8.5 mm long, 70 µm lumen) is made from SIBS (poly[styrene-block-isobutylene-block-styrene]). We present the 12-month interim analysis of a prospective, multicenter, open-label, 24-month study (NCT02177123), which evaluates the efficacy and safety of the MicroShunt in patients with primary open-angle glaucoma.

Methods : The study was conducted in France, The Netherlands, Spain and Switzerland. The MicroShunt was implanted ab externo with topical Mitomycin C (0.2–0.4 mg/mL) for 2–3 minutes, then rinsed with saline, in patients not controlled on maximum tolerated medical therapy with intraocular pressure (IOP) ≥18 and ≤35 mmHg. Primary outcomes were reduction in IOP from baseline to Month 12 (overall success: IOP <21 mmHg and ≥20% reduction with or without medications, no reoperation for glaucoma or loss of light perception) and incidence of device- and/or procedure-related adverse events (AEs). Secondary outcome measures included glaucoma medication use.

Results : Overall, 101 patients were implanted with the MicroShunt. Baseline mean ± standard deviation IOP and medications/patient were 21.5±4.2 mmHg and 2.2±1.3, respectively. At Month 12, IOP was 14.9±4.4 mmHg (27% reduction; data not censored for failed cases; n=89); 70% of patients had overall success. At Month 12, 67% of patients were medication free. Before Month 12, there with 13 bleb revisions, with one conversion to trabeculectomy and two conversions to Baerveldt devices. The most common AEs were hypotony (10%) and shallow chambers (5%); both of which resolved spontaneously. Ten needlings (10%) were reported. There were no reports of long-term sight-threatening AEs.

Conclusions : These interim 12-month results support previous studies; the MicroShunt decreased IOP and the number of glaucoma medications with an acceptable safety and tolerability profile.
Sponsored by InnFocus, a Santen company.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.

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