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Abstract #99278 Published in IGR 22-4
Use of a Novel Microshunt in Refractory Childhood Glaucoma Initial experience in a Compassionate Use / Early Access Cohort
Brandt JDAmerican Journal of Ophthalmology 2022; 239: 223-229
PURPOSE: In refractory childhood glaucoma, 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 & 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 refractory childhood glaucoma in patients who would otherwise undergo trabeculectomy or implantation of a GDD. DESIGN: Prospective single-center case series under FDA compassionate-use Investigational Device Exemption (IDE) METHODS: FDA and IRB approvals were obtained to treat up to 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 at least 1 year follow-up are reported. RESULTS: Twelve eyes of 12 children (15 months - 14 years with mean preoperative IOP 22.72±4.8 mmHg on 3.3±0.65 medications were treated beginning in December 2019. No intraoperative complications occurred. Among eyes with at least 1 year of follow-up (range 12-23 months), 9 were successfully controlled - in this group preoperative IOP 21.6±4.9 mmHg dropped 45% to 11.9±3.8 mmHg at one year; seven were on no medications at 12 months, two required 2 medications (fixed-combination dorzolamide-timolol). Three eyes failed, requiring additional surgery. CONCLUSION: This early data suggest that the device is safe and appears effective in refractory childhood glaucoma. A prospective, multi-center pivotal trial is planned.
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