July 2019
Volume 60, Issue 9
Open Access
ARVO Annual Meeting Abstract  |   July 2019
First-in-man clinical study on a novel glaucoma drainage implant for refractory glaucoma
Author Affiliations & Notes
  • Victor T C Koh
    Ophthalmology, National University Hospital, Singapore
    National University of Singapore, Singapore
  • Cecilia Maria Aquino
    Ophthalmology, National University Hospital, Singapore
  • Paul Chew
    Ophthalmology, National University Hospital, Singapore
    National University of Singapore, Singapore
  • Keith Barton
    Moorfields Eye Hospital, United Kingdom
  • Footnotes
    Commercial Relationships   Victor Koh, None; Cecilia Aquino, None; Paul Chew, Advanced Ophthalmic Innovations (P); Keith Barton, Alcon (C), Allergan (F), Amakem (S), Aquesys (C), Aquesys (I), Carl Zeiss Meditec (C), EyeTechCare (F), Glaukos (S), Ivantis (S), Kowa (S), Merck (S), Refocus (S), Santen (C), Thea (S), Transcend Medical (C), Vision Futures (UK) Ltd (I), Vision Medical Events Ltd (I)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science July 2019, Vol.60, 3762. doi:https://doi.org/
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      Victor T C Koh, Cecilia Maria Aquino, Paul Chew, Keith Barton; First-in-man clinical study on a novel glaucoma drainage implant for refractory glaucoma. Invest. Ophthalmol. Vis. Sci. 2019;60(9):3762. doi: https://doi.org/.

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

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Abstract

Purpose : To determine the one-year safety and efficacy of the Paul Glaucoma Implant, a novel glaucoma drainage implant in eyes with refractory glaucoma

Methods : This is a non-comparative prospective interventional first-in-man study involving six participants with refractory glaucoma, defined as suboptimal intraocular pressure (IOP), despite maximal tolerable medical therapy, in a single centre in Singapore. All subjects underwent successful implantation of the Paul Glaucoma Implant, which has a reduced tube internal diameter (0.127mm) compared with conventional shunts, but a large plate surface area (342.1mm2). The primary end point included IOP reduction, number of IOP-lowering medicines and complications. All subjects completed one-year of follow-up with fixed follow-up visits (1 day, 1 week, 3 months, 6 months and 12 months).

Results : The mean age was 61.3 ± 4.9 years; all were male and included 2 with primary open angle glaucoma, 2 secondary open angle glaucomas, 1 traumatic glaucoma and 1 chronic angle closure glaucoma. Compared to the mean highest pre-operative IOP (35.2 ± 9.1 mmHg), there was a statistically significant lower mean post-operative IOP at 3, 6 and 12 months (13.7 ± 3.8 , 13.8 ± 3.4 and 12.8 ± 3.2 mmHg respectively [P<0.001]). There was a mean 62.9 ± 0.1 % reduction in IOP at one year after surgery. The mean number of IOP-lowering medications before and 1 year after surgery was 2.7 ± 1.0 and 0.33 ± 0.8 respectively (P=0.005). There were no intra-operative complications; 1 eye (16.7%) required post-operative laser iridoplasty to release the iris plugging the tube, and 2 eyes (33.3%) had self-limiting shallow anterior chambers, both of which recovered by 1 month after surgery.

Conclusions : In this first-in-man clinical study, the Paul Glaucoma Implant showed a good safety profile and efficacy in IOP reduction and reduction in IOP lowering medications after 1 year of follow-up.

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

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