September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Supraciliary viscoexpansion with microstenting for IOP lowering in open-angle glaucoma: first-in-human feasibility study
Author Affiliations & Notes
  • Quang Nguyen
    Ophthalmology, Scripps Clinic, La Jolla, California, United States
  • Tsontcho Ianchulev
    Transcend Medical, Menlo Park, California, United States
    University of California, San Francisco, California, United States
  • Steven Vold
    Vold Vision, Fayetteville, Arkansas, United States
  • Helmut Hoeh
    Ophthalmology, Dietrich Bonhoeffer Hospital, Neubrandenburg, Germany
  • Salvatore Grisanti
    University Clinic, Schleswig-Holstein, Lübeck, Germany
  • Swaantje Grisanti
    University Clinic, Schleswig-Holstein, Lübeck, Germany
  • Ernesto Calvo
    Ruben Orillac Clinic, Panama City, Panama
  • Ruben Orillac
    Ruben Orillac Clinic, Panama City, Panama
  • Andrea Vasquez
    Ruben Orillac Clinic, Panama City, Panama
  • Iqbal K Ahmed
    Ophthalmology, University of Toronto, Toronto, Ontario, Canada
    Trillium Health Partners and Credit Valley EyeCare, Mississauga, Ontario, Canada
  • Footnotes
    Commercial Relationships   Quang Nguyen, Transcend Medical (F), Transcend Medical (R); Tsontcho Ianchulev, Transcend Medical (E); Steven Vold, Transcend Medical (C), Transcend Medical (F), Transcend Medical (R); Helmut Hoeh, Transcend Medical (F), Transcend Medical (R); Salvatore Grisanti, Transcend Medical (F); Swaantje Grisanti, Transcend Medical (F); Ernesto Calvo, Transcend Medical (F), Transcend Medical (R); Ruben Orillac, Transcend Medical (F), Transcend Medical (R); Andrea Vasquez, Transcend Medical (F), Transcend Medical (C), Transcend Medical (R); Iqbal Ahmed, Transcend Medical (C)
  • Footnotes
    Support  Transcend Medical
Investigative Ophthalmology & Visual Science September 2016, Vol.57, 6503. doi:
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      Quang Nguyen, Tsontcho Ianchulev, Steven Vold, Helmut Hoeh, Salvatore Grisanti, Swaantje Grisanti, Ernesto Calvo, Ruben Orillac, Andrea Vasquez, Iqbal K Ahmed; Supraciliary viscoexpansion with microstenting for IOP lowering in open-angle glaucoma: first-in-human feasibility study. Invest. Ophthalmol. Vis. Sci. 2016;57(12):6503.

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

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Abstract

Purpose : This is the first-in-human report of ab-interno suprachoroidal viscoexpansion with supraciliary microstenting for treating primary open-angle glaucoma (POAG).

Methods : Multicenter, interventional, randomized, controlled, pilot study. Patients had POAG (Shaffer Grade 3-4) and baseline intraocular pressure (IOP) >21 mmHg. After medication wash-out, 63 subjects (63 eyes) were randomized to three groups (n=21/group): Implantation with Stent-only or with concomitant 30 or 60 µl suprachoroidal adaptive viscoelastic spacer injection (Groups V30 and V60). Viscoelastic was ab-interno injected into the supraciliary space through the guidewire of the microstent delivery device, through a 1.5 mm paracentesis, ≈5 mm posterior to the limbus. Adverse events (AEs), IOP changes, and IOP-lowering medications required during postoperative 12-months were monitored.

Results : Stent-only, V30, and V60 groups had respective baseline medicated IOPs (mean±SD) of 22.2±5.8, 22.5±6.5, and 22.4±5.7 mmHg, and washed-out IOPs of 25.3±3.7, 27.1±5.5, and 26.6±6.2 mmHg. All surgeries were successful, with no serious intraoperative events or major AEs. Minor AE frequencies, including transient IOP increase, transient hyphema, and visually-significant cataract progression were low and similar in all groups. Mean IOPs in Stent-only, V30, and V60 groups dropped to 18.3±4.4, 18.4±8.3, and 16.7±3.7 mmHg. Twelve-month IOP changes in Stent-only, V30, and V60 groups were -7.0±4.2, -8.7±7.8, and -9.9±5.8 mmHg, suggesting a dose-response trend. From baseline to 12 months, medication use decreased from 1.2±1.2 to 0.4±0.7 medications in Stent-only, 1.4±1.6 to 1.0±1.4 drugs in V30, and 1.0±1.1 to 0.7±1.1 medications in V60.

Conclusions : Supraciliary viscoexpansion with microstenting was successfully achieved through an ab-interno approach, and significantly lowered IOP and glaucoma medication use.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

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