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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.
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© ARVO (1962-2015); The Authors (2016-present)
To determine the one-year safety and efficacy of the Paul Glaucoma Implant, a novel glaucoma drainage implant in eyes with refractory glaucoma
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).
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.
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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