Biotissue stent for supraciliary outflow in open-angle glaucoma patients: surgical procedure and first clinical results of an aqueous drainage biostent

Abstract

Background/aimsTo report a first-in-human trial in open-angle glaucoma (OAG) subjects treated with a new microinterventional biostent-reinforced cyclodialysis technique to enhance supraciliary aqueous drainage.MethodsSubjects (N=10; 74.1±7.9 years old) with OAG and cataracts underwent combined phacoemulsification cataract surgery with implantation of a permanent endoscleral supraciliary biostent to reinforce a controlled cyclodialysis cleft. The biostent comprised decellularised scleral allograft tissue microtrephined into a polymer tubular implant intraoperative/postoperative safety, intraocular pressure (IOP) and glaucoma medications were tracked through 12 months postimplantation.ResultsBaseline medicated IOP averaged 24.2±6.9 mm Hg with subjects using 1.3±0.8 IOP-lowering medications. Successful biostent implantation was achieved in all individuals without significant complications. Immediate IOP lowering was sustained through 1 year. Twelve-month mean IOP was reduced 40% from baseline to 14.6±3.2 mm Hg (p=0.004; paired two-tailed t-test), and 80% of patients achieved >20% IOP reduction. Biostenting reduced glaucoma medication use 62%, from a baseline mean of 1.3 required medications to 0.5 medications (p=0.037) at postoperative 12 months. The biotissue implant was well tolerated and demonstrated good endothelial safety with only 11% endothelial cell loss at 12 months after combined phaco-biostenting surgery, similar to that expected after phacoemulsification alone. Mean BCVA increased from baseline 20/130 Snellen to 20/36 at postoperative 12 months (p=0.001).ConclusionSupraciliary biostenting in OAG patients is well tolerated, has a good safety profile and produces long-term IOP-lowering while reducing glaucoma medication requirements.

Minimally Invasive Glaucoma Surgery: Latest Developments and Future Challenges

“…The first-in-human study of 10 patients has been published. 118 Tapping into the suprachoroidal pathway will give our patients another target to reduce IOP. It will be particularly useful when bleb surgeries are not possible or have failed.…”

“…It is delivered by a cyclodialysis microcannula (CycloPen, IANTREK) and expands by 10% on insertion. The first-in-human study of 10 patients has been published 118 …”

Glaucoma surgical procedures under development

“…Endothelial cell density decreased by 5%. Ianchulev et al [17] described supraciliary placement of a scleral allograft implant. They reported a reduction in IOP sustained at 12 months.…”

New Devices in Glaucoma

“…This biostent is a permeable scleral allograft of homologous acellular matrix designed to minimize the negative effects of synthetic foreign material in the eye [ 45 ] (Fig. 6 ).…”

“…The device demonstrated an 11% endothelial cell loss at 12 months after combined phaco-biostenting surgery. Manufacturers are currently planning a larger study involving multiple sites globally to further assess the safety and efficacy of the device [ 45 ].

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