Elbaklish Khaled Hamdi, Gomaa Wael Adel
Ophthalmology Department, Ain Shams University, Cairo, Egypt.
Clin Ophthalmol. 2020 Mar 4;14:693-705. doi: 10.2147/OPTH.S224653. eCollection 2020.
To compare a range of clinical outcome variables (intraocular pressure, glaucoma medications, visual acuity, and complications) between two Ahmed glaucoma valve (AGV) models (S2 and FP7).
This was a prospective and randomized clinical trial. Fifty-six patients with refractory glaucoma were randomly assigned to be implanted with either a polypropylene (S2) or silicone (FP7) Ahmed glaucoma valve. The primary outcome measure was a surgical success, defined as an IOP ≤ 16 mm Hg (without medication), and guarded success, defined as a controlled IOP ≤ 16 mmHg (with medication). Failure was defined as when the IOP lay outside of the successful range on two consecutive visits (>16 mmHg, despite medication).
Mean follow-up period was 398.42 ± 12.34 days (range, 380-420 days) for the S2 group and 401.75 ± 9.78 days (range, 385-420 days) for the FP7 group; these values were not significantly different (P = 0.27). After 12 months of follow-up, the baseline IOP (45.42 mmHg) fell significantly to 16.14 mmHg in the S2 group (p < 0.000); there was also a significant reduction in IOP in the FP7 group (from 44.17 mmHg to 15.18 mmHg in FP7 group, p < 0.000). At the last follow-up examination, the mean IOP in the S2 group was 16.14 ± 3.18 mmHg, while that of the FP7 group was 15.18 ± 2.75 mmHg; there was no significant difference between the two groups with this respect (p = 0.23). The mean number of medications used by patients in the S2 and FP7 groups was 2.92 ± 1.27 and 2.75 ± 1.43, respectively; there was no significant difference between the two groups with this respect (p = 0.32). There was no significant difference between the FP7 and S2 groups with regard to their relative success rate (17.89% [5/28] versus 10.7% [3/28], respectively; p = 0.38).
Our data show that the S2 and FP7 models of AGV were both effective in lowering IOP and reducing the need for glaucoma medications. Although these two AGV models had similar dimensions, they were constructed from different materials. However, there were no significant clinical differences between the S2 and FP7 AGV groups after 12 months of follow-up. Furthermore, our data indicate that bleb encapsulation was the primary factor responsible for failure rate and the need for glaucoma medication in both the S2 and FP7 groups. Our analysis further indicates that the S2 and FP7 Ahmed valves are associated with a high risk of failure when considered as a first-line therapy for cases experiencing trabeculectomy.
NCT04214847.
比较两种艾哈迈德青光眼引流阀（AGV）型号（S2和FP7）之间一系列临床结局变量（眼压、青光眼药物使用情况、视力和并发症）。
这是一项前瞻性随机临床试验。56例难治性青光眼患者被随机分配植入聚丙烯（S2）或硅胶（FP7）艾哈迈德青光眼引流阀。主要结局指标为手术成功，定义为眼压≤16 mmHg（无需药物治疗），以及保护性成功，定义为眼压控制在≤16 mmHg（需药物治疗）。失败定义为连续两次就诊时眼压超出成功范围（尽管使用药物治疗，眼压仍>16 mmHg）。
S2组平均随访期为398.42±12.34天（范围380 - 420天），FP7组为401.75±9.78天（范围385 - 420天）；两组数值无显著差异（P = 0.27）。随访12个月后，S2组基线眼压（45.42 mmHg）显著降至16.14 mmHg（p < 0.000）；FP7组眼压也显著降低（从44.17 mmHg降至15.18 mmHg，p < 0.000）。在最后一次随访检查时，S2组平均眼压为16.14±3.18 mmHg，而FP7组为15.18±2.75 mmHg；两组在这方面无显著差异（p = 0.23）。S2组和FP7组患者使用药物的平均数量分别为2.92±1.27和2.75±1.43；两组在这方面无显著差异（p = 0.32）。FP7组和S2组的相对成功率无显著差异（分别为17.89%[5/28]和10.7%[3/28]；p = 0.38）。
我们的数据表明，AGV的S2和FP7型号在降低眼压和减少青光眼药物使用需求方面均有效。尽管这两种AGV型号尺寸相似，但由不同材料制成。然而，随访12个月后，S2和FP7 AGV组之间无显著临床差异。此外，我们的数据表明，滤过泡包裹是S2和FP7组失败率和青光眼药物使用需求的主要影响因素。我们的分析进一步表明，对于经历小梁切除术的病例，将S2和FP7艾哈迈德引流阀作为一线治疗时，失败风险较高。
NCT04214847。
