Three-year follow-up of a novel aqueous humor microshunt

Juan F. Batlle, Francisco Fantes, Isabelle Riss, Leonard Pinchuk, Rachel Alburquerque, Yasushi P. Kato, Esdras Arrieta Quintero, Adalgisa Corona Peralta, Paul Palmberg, Richard K Parrish, Bruce A. Weber, Jean-Marie A Parel

Research output: Contribution to journalArticle

30 Scopus citations

Abstract

Aims: An observational study to determine the safety and efficacy of filtering surgery employing a microlumen aqueous drainage device (InnFocus MicroShunt), used intraoperatively with Mitomycin C, implanted alone or in combination with phacoemulsification. Materials and Methods: Single-site, prospective, nonrandomized study of 23 eyes that had failed maximum tolerated glaucoma medication, followed for 3 years. A MicroShunt was implanted ab externo through a needle tract under the limbus, draining aqueous from the anterior chamber to the scleral surface. Prespecified outcome measures include: intraocular pressure (IOP) control, with and without supplemental medication, success rate, medication use, and adverse events. Results: Fourteen patients received the MicroShunt alone and 9 with cataract surgery. At 1 (n=23), 2 (n=22), and 3 (n=22) years of follow-up; the qualified success rate (IOP≤14mm Hg and IOP reduction ≥20%) was 100%, 91%, and 95%; mean medicated IOP was reduced from 23.8±5.3 to 10.7±2.8, 11.9±3.7, and 10.7±3.5mm Hg, and the mean number of glaucoma medications/ patient was reduced from 2.4±0.9 to 0.3±0.8, 0.4±1.0, and 0.7±1.1, respectively. The most common complications were transient hypotony (13%, 3/23) and transient choroidal effusion (8.7%, 2/23), all resolved spontaneously. There were no leaks, infections, migrations, erosions, persistent corneal edema, or serious long-term adverse events. Conclusion: Surgery with the InnFocus MicroShunt transscleral aqueous drainage tube with Mitomycin C achieved IOP control in the low teens in most subjects up to 3 years of follow-up with only transient adverse events occurring within the first 3 months after surgery.

Original languageEnglish (US)
Pages (from-to)e58-e65
JournalJournal of Glaucoma
Volume25
Issue number2
DOIs
StatePublished - Jan 28 2016

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Keywords

  • Aqueous humor
  • Glaucoma
  • Glaucoma drainage tube
  • Minimally invasive surgery
  • Shunt
  • Treatment surgery

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Batlle, J. F., Fantes, F., Riss, I., Pinchuk, L., Alburquerque, R., Kato, Y. P., Arrieta Quintero, E., Peralta, A. C., Palmberg, P., Parrish, R. K., Weber, B. A., & Parel, J-M. A. (2016). Three-year follow-up of a novel aqueous humor microshunt. Journal of Glaucoma, 25(2), e58-e65. https://doi.org/10.1097/IJG.0000000000000368