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