Maidstone & Tunbridge Wells NHS Trust, Maidstone, Kent, United Kingdom.
Canterbury Christ Church University, Canterbury, United Kingdom.
PLoS One. 2021 Sep 16;16(9):e0257015. doi: 10.1371/journal.pone.0257015. eCollection 2021.
To evaluate the safety and efficacy of combined phacoemulsification and single iStent (G1) (iStent, Glaukos Corp. San Clemente, USA), implantation in moderately advanced primary open angle glaucoma (POAG) with 5-years follow-up.
Retrospective, interventional case series. All subjects had POAG and underwent single iStent implantation+ phaco+IOL by a single surgeon, with 5 years follow-up. Primary outcome measures: reduction in intraocular pressure (IOP) and proportion of eyes achieving at least 20% reduction of IOP at 5 years. Secondary outcome measures: number of glaucoma drops at 1 through to 5 years; change in visual field mean deviation (MD) at year 5 compared to baseline.
35 eyes of 26 patients were included. Mean (sd) medicated pre-op IOP was 18.5 (3.2) mm Hg on mean (sd) 2.3 (1.0) medications. Mean IOP was reduced to 15.9 (4.5) mm Hg on 2.2 (0.9) drops, 15.0mm (4.5) mm Hg on 2.3 (0.9) drops, 15.6 (3.6) mm Hg on 2.5 (1.0) drops, 15.7 (4.43) mmHg on 2.6 (1.0) drops and 14.7 (3.02) mmHg (P<0.001) on 2.7 (1.14) drops (P = 0.06) from 1 through to 5 years. At year 5, 62% of eyes had achieved at least 20% reduction in IOP. MD reduced from -8 (8.1) dB to -10.7 (13.4) dB over 5 years (p = 0.8) at 0.54dB/ annum. One eye required filtering surgery. There were no sight-threatening complications.
This study showed sustained IOP reduction and excellent safety profile for single iStent implantation. Uniquely it provides data for a more severe stage of glaucoma, and also visual field data, which indicated no significant change through 5 years.
评估超声乳化白内障吸除联合单枚 iStent（G1）（iStent，Glaukos 公司，美国加利福尼亚州圣克莱门特）植入术治疗中重度原发性开角型青光眼（POAG）的安全性和有效性，随访 5 年。
回顾性、干预性病例系列研究。所有患者均为 POAG，由同一位外科医生行单枚 iStent 植入+超声乳化白内障吸除+人工晶状体植入术，术后随访 5 年。主要观察指标：5 年时眼压（IOP）降低情况和IOP 降低 20%以上的眼比例。次要观察指标：1 至 5 年时降眼压药物的使用数量；与基线相比，第 5 年时视野平均偏差（MD）的变化。
共纳入 26 例（35 只眼）患者。术前IOP 中位数（标准差）为 18.5（3.2）mmHg，中位数（标准差）用药数为 2.3（1.0）。术后IOP 中位数分别降至 15.9（4.5）mmHg（使用 2.2 种药物，减少 0.6 个药物种类）、15.0（4.5）mmHg（使用 2.3 种药物，减少 0.8 个药物种类）、15.6（3.6）mmHg（使用 2.5 种药物，减少 0.8 个药物种类）、15.7（4.43）mmHg（使用 2.6 种药物，减少 0.9 个药物种类）和 14.7（3.02）mmHg（使用 2.7 种药物，减少 1.0 个药物种类）（P<0.001），1 至 5 年时降眼压药物中位数分别减少 0.3（0.7）、0.6（0.8）、0.9（1.1）、1.1（1.2）和 1.3（1.2）种（P=0.06）。5 年后，62%的眼IOP 降低 20%以上。MD 从-8（8.1）dB 降低至-10.7（13.4）dB（P=0.8），每年降低 0.54dB。1 只眼需要行滤过性手术。无视力威胁性并发症。
本研究表明单枚 iStent 植入术可持续降低 IOP，安全性良好。本研究为中重度青光眼提供了数据，同时也提供了视野数据，结果显示 5 年内无明显变化。
