Use of a Novel Microshunt in Refractory Childhood Glaucoma: Initial Experience in a Compassionate Use/Early Access Cohort.

ABSTRACT

PURPOSE: In patients with refractory childhood glaucoma, treatment options include trabeculectomy or large glaucoma drainage devices (GDDs) with attendant short- and long-term risks. A novel polymer-based microshunt is under review by the US Food and Drug Administration (FDA) for use in adults. The device is attractive for children given the long-term stability of the polymer and the small conjunctival incision required for implantation. This early clinical series explores the safety and efficacy of this device in patients with refractory childhood glaucoma who would otherwise undergo trabeculectomy or implantation of a GDD. DESIGN: Prospective single-center case series under FDA compassionate use investigational device exemption. METHODS: FDA and institutional review board approvals were obtained to treat ≤20 children using this investigational device under the compassionate use pathway. Single eyes in patients with refractory childhood glaucoma were treated surgically with the microshunt. Patients with ≥1 year of follow-up are reported. RESULTS: Twelve eyes of 12 children (15 months to 14 years if age) with mean preoperative intraocular pressure of 22.72 ± 4.8 mm Hg on 3.3 ± 0.65 medications were treated beginning in December 2019. No intraoperative complications occurred. Among eyes with ≥1 year of follow-up (range 12-23 months), 9 were successfully controlled. In this group, preoperative intraocular pressure 21.6 ± 4.9 mm Hg dropped 45% to 11.9 ± 3.8 mm Hg at 1 year; 7 patients were taking no medications at 12 months, and 2 required 2 medications (fixed-combination dorzolamide-timolol). Three eyes failed, requiring additional surgery. CONCLUSION: These early data suggest that the device is safe and appears effective in patients with refractory childhood glaucoma. A prospective, multicenter pivotal trial is planned.