July 2019
Volume 60, Issue 9
Free
ARVO Annual Meeting Abstract  |   July 2019
InnFocus MicroShunt for the Treatment of Primary Open Angle Glaucoma: Safety & Preliminary Outcomes at 18 months.
Author Affiliations & Notes
  • Giacinto Triolo
    Glaucoma Service, Moorfields Eye Hospital, London, United Kingdom
  • Keith Barton
    Glaucoma Service, Moorfields Eye Hospital, London, United Kingdom
    NIHR Moorfields Biomedical Research Centre, London, United Kingdom
  • Gus Gazzard
    Glaucoma Service, Moorfields Eye Hospital, London, United Kingdom
    NIHR Moorfields Biomedical Research Centre, London, United Kingdom
  • Nicholas Strouthidis
    Glaucoma Service, Moorfields Eye Hospital, London, United Kingdom
    NIHR Moorfields Biomedical Research Centre, London, United Kingdom
  • Peng Tee Khaw
    Glaucoma Service, Moorfields Eye Hospital, London, United Kingdom
    NIHR Moorfields Biomedical Research Centre, London, United Kingdom
  • Hari Jayaram
    Glaucoma Service, Moorfields Eye Hospital, London, United Kingdom
    NIHR Moorfields Biomedical Research Centre, London, United Kingdom
  • Footnotes
    Commercial Relationships   Giacinto Triolo, None; Keith Barton, Allergan, Alcon, Laboratoires Thea, EyeTechCare (R), AMO, Merck, Allergan, Aquesys, Laboratories Thea (F), Glaukos, Alcon, Allergan, Kowa, Laboratoires Thea, Ivantis, Santen (S), Pharmaceutical Co. Ltd, Transcend Medical, Calpain Therapeutics, PhPharma, iStar (C); Gus Gazzard, None; Nicholas Strouthidis, None; Peng Khaw, None; Hari Jayaram, Allergan (C), Santen (R), Thea (R)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 5243. doi:
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      Giacinto Triolo, Keith Barton, Gus Gazzard, Nicholas Strouthidis, Peng Tee Khaw, Hari Jayaram; InnFocus MicroShunt for the Treatment of Primary Open Angle Glaucoma: Safety & Preliminary Outcomes at 18 months.. Invest. Ophthalmol. Vis. Sci. 2019;60(9):5243.

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

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Abstract

Purpose : To evaluate the preliminary safety and efficacy of the InnFocus MicroShunt (IMS) for the surgical treatment of Primary Open Angle Glaucoma (POAG).

Methods : Retrospective case-note review of all patients with a diagnosis of POAG who underwent IMS insertion augmented with mitomycin-C at Moorfields Eye Hospital between January 2016 and November 2018. Intraocular Pressure (IOP) and the number of topical IOP-lowering medications were noted at baseline, and at 3,6,12 & 18 months after surgery. The details of any early (≤1 month post-surgery) or late (≥3 month post-surgery) complications during follow-up were recorded.

Results : 34 eyes from 29 patients underwent IMS insertion during the study period. The mean duration of follow up was 11.9±10.3 months. The baseline IOP (mean±SD) was 22.0±6.9mmHg, and reduced to 14.1±5.6mmHg (36.1% reduction from baseline), 13.4±3.5 mmHg (39.2% reduction from baseline), 14.1±3.3mmHg (36.2% reduction from baseline), 14.0±3.1mmHg (36.5% reduction from baseline) at months 3,6,12 &18 respectively (all p values <0.01). The number of topical IOP-lowering medications (mean±SD) at baseline was 3.1±0.8, and reduced to 0.2±0.7, 0.2±0.6, 0.3±0.7 & 0.4±0.8 at months 3,6,12 &18 respectively (all p values <0.01). Transient early complications (≤1 month post-surgery) included hyphema (3/34 eyes, 8.8%), hypotony with choroidal effusion (3/34 eyes, 8.8%), diplopia (1/34 eyes, 2.9%). There was no occurrence of late hypotony, bleb leak, bleb-related infection, ptosis or significant visual loss. Three out of 34 eyes underwent cataract surgery during the follow up period. Bleb needling +/- sub-conjunctival 5-fluorouracil or steroid injection was performed in 2/34 (5.9%), 1/34 (2.9%), 1/34 (2.9%) eyes at month 1, 3 & 18, respectively. 2/34 (5.9%) eyes required surgical revision at month 3.

Conclusions : IMS insertion augmented with mitomycin-C shows good preliminary efficacy with a favourable safety profile for the surgical treatment of POAG. Future reporting of randomized controlled clinical trials will provide a head-to head comparison of this new intervention to the current gold standard of trabeculectomy.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.

 

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