Ophthalmology Unit, Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine, University of Pisa, Pisa, Italy.
Ophthalmology Clinic, Department of Medicine and Aging Science, University G. D'Annunzio of Chieti-Pescara, Chieti, Italy.
Acta Ophthalmol. 2022 May;100(3):e753-e759. doi: 10.1111/aos.14989. Epub 2021 Jul 27.
To evaluate the 10-year follow-up efficacy and safety of gold micro shunt (GMS) in patients with refractory glaucoma, and the potential risk factors for failure.
Retrospective data analyses based on medical records from 55 patients who underwent GMS implant for refractory glaucoma between March 2007 and April 2008. The primary outcome measure was the cumulative probability of success defined as intraocular pressure (IOP) below 21 mmHg together with a 33% lowering of the baseline IOP with (qualified) or without (complete) topical medications, no reoperation for glaucoma or loss of light perception.
Mean IOP 10 years after the GMS implantation was 21.6 ± 5.1 mmHg with 2.7 ± 0.7 drugs. Qualified success was achieved in 8/55 patients (14.5%) with a mean of 2.9 ± 0.8 drugs at 5 years and in 2/55 patients (3.6%) with a mean of 2.7 ± 1.0 drugs at 10 years. None of the patients reached complete success at five years from surgery. The cumulative probability of complete success was 14%, 9% and 0% at 1, 2 and 5 years, respectively, and 72%, 67%, 36% and 3.6% at 1, 2, 5 and 10 years, respectively, for qualified success criterion. Baseline IOP for complete success, number of baseline medication for qualified success and age at the time of GMS implantation for both criteria were risk factors significantly associated with failure.
A very low long-term survival rate of GMS in refractory glaucoma was found. Most patients did not reach the IOP success criteria of the study, even with the re-introduction of medications, leading to the need for further surgical procedures.
评估金微管（GMS）在难治性青光眼患者中的 10 年随访疗效和安全性，以及失败的潜在危险因素。
回顾性病历数据分析，纳入 2007 年 3 月至 2008 年 4 月期间因难治性青光眼接受 GMS 植入术的 55 例患者。主要观察指标为定义为眼压（IOP）低于 21mmHg，且与基线IOP相比降低 33%，同时无需（合格）或无需（完全）局部药物治疗、无需再次进行青光眼手术或视力丧失的累积成功率。
GMS 植入后 10 年平均眼压为 21.6±5.1mmHg，用药 2.7±0.7 种。5 年时，8/55 例（14.5%）患者达到合格成功，平均用药 2.9±0.8 种；10 年时，2/55 例（3.6%）患者达到合格成功，平均用药 2.7±1.0 种。手术后 5 年无患者达到完全成功。完全成功的累积概率分别为 14%、9%和 0%，合格成功标准的累积概率分别为 72%、67%、56%和 3.6%，1、2、5 和 10 年。完全成功的基线眼压、合格成功的基线用药数量和 GMS 植入时的年龄是与失败显著相关的危险因素。
难治性青光眼患者 GMS 的长期生存率非常低。大多数患者即使重新引入药物治疗也未能达到研究的 IOP 成功标准，导致需要进一步的手术治疗。
