From the Department of Ophthalmology and Vision Science, University of California, Davis, Sacramento, California, USA.
Am J Ophthalmol. 2022 Jul;239:223-229. doi: 10.1016/j.ajo.2022.03.021. Epub 2022 Mar 26.
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.
Prospective single-center case series under FDA compassionate use investigational device exemption.
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.
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.
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.
对于难治性儿童青光眼患者，治疗选择包括小梁切除术或大型青光眼引流装置（GDD），但存在短期和长期风险。一种新型聚合物微分流器正在接受美国食品和药物管理局（FDA）的审查，以用于成人。鉴于聚合物的长期稳定性和植入所需的小结膜切口，该设备对儿童具有吸引力。本早期临床系列探讨了该设备在否则需要接受小梁切除术或 GDD 植入的难治性儿童青光眼患者中的安全性和有效性。
在 FDA 同情使用调查设备豁免下进行的前瞻性单中心病例系列研究。
获得了 FDA 和机构审查委员会的批准，以便根据同情使用途径，使用该研究性设备治疗最多 20 名儿童。将难治性儿童青光眼患者的单眼手术治疗采用微分流器。报告了随访时间≥ 1 年的患者。
2019 年 12 月开始，12 名儿童的 12 只眼（年龄 15 个月至 14 岁）接受了治疗，平均术前眼压为 22.72±4.8mmHg，使用 3.3±0.65 种药物。术中无并发症发生。在随访时间≥ 1 年的眼中（范围 12-23 个月），9 只眼成功控制。在这一组中，术前眼压 21.6±4.9mmHg 在 1 年内下降了 45%，至 11.9±3.8mmHg；7 名患者在 12 个月时无需用药，2 名患者需要 2 种药物（固定组合多佐胺-噻吗洛尔）。3 只眼失败，需要进一步手术。
这些早期数据表明该设备在难治性儿童青光眼患者中是安全且有效的。计划进行一项前瞻性、多中心的关键性试验。
