Gallardo Mark J, Porter Matthew
El Paso Eye Surgeons, PA, 1201 North Mesa Street, Suite G, El Paso, TX, 79902, USA.
Department of Ophthalmology, Texas Tech University Health Sciences Center in Lubbock, 3601, 4th St, Lubbock, TX, 79430, USA.
Ophthalmol Ther. 2023 Aug;12(4):1973-1987. doi: 10.1007/s40123-023-00726-9. Epub 2023 May 13.
This study evaluated efficacy and safety of implanting two second-generation trabecular micro-bypass stents (iStent inject/iStent inject W) with phacoemulsification, either with or without iAccess Precision Blade goniotomy, in patients with mild-to-moderate open-angle glaucoma (OAG).
This retrospective, non-randomized, unmasked, dual-arm, single-site, multi-surgeon, consecutive case series evaluated all OAG eyes that underwent phacoemulsification and iStent inject implantation either as a dual procedure (group A) or paired with iAccess goniotomy (group B) from July 2020 to May 2022. Effectiveness outcomes analyzed from 1 month onward included intraocular pressure (IOP), proportions of eyes with IOP ≤ 12/≤ 15/≤ 18, proportion medication-free, and medication number. Safety outcomes at all timepoints included adverse events and secondary surgeries.
In group A, mean IOP reduced from 14.9 ± 3.2 mmHg on 1.22 ± 1.31 mean medications preoperatively (n = 63) to 13.5 ± 2.5 mmHg on 0.24 ± 0.61 medications at month 3 (n = 34; p = 0.048 IOP, p < 0.001 medications). In group B, mean IOP reduced from 16.0 ± 4.2 mmHg on 1.12 ± 1.07 medications preoperatively (n = 93) to 12.2 ± 2.3 mmHg on 0.57 ± 1.27 medications at month 3 (n = 23; p < 0.001 IOP, p = 0.003 medications). From preoperative to 3 months, the percent of eyes with IOP ≤ 12 mmHg remained at 32.4% in group A (p = 1.0) and rose from 21.7% to 60.9% in group B (p = 0.0177); eyes with IOP ≤ 15 mmHg rose from 52.9% to 76.5% in group A (p = 0.0963) and from 43.5% to 91.3% in group B (p = 0.0034). Adjusting for baseline between-group differences, group B had significantly greater postoperative IOP reduction than group A (p = 0.043); medication reductions were similar. Safety was favorable in both groups.
Phacoemulsification and iStent inject with or without iAccess Precision Blade goniotomy produced clinically meaningful and safe IOP and medication reductions. The paired iStent inject + iAccess + phacoemulsification procedure enabled greater IOP reduction and lower IOP thresholds than iStent inject + phacoemulsification. The study provides some of the first data on this paired approach and on the novel iAccess Precision Blade.
本研究评估了在轻度至中度开角型青光眼（OAG）患者中，植入两个第二代小梁微旁路支架（iStent inject/iStent inject W）联合超声乳化手术，无论是否联合iAccess Precision Blade前房角切开术的有效性和安全性。
本回顾性、非随机、非盲、双臂、单中心、多术者、连续病例系列研究评估了2020年7月至2022年5月期间所有接受超声乳化联合iStent inject植入术的OAG患眼，其中一部分作为联合手术（A组），另一部分联合iAccess前房角切开术（B组）。从术后1个月起分析的有效性指标包括眼压（IOP）、IOP≤12/≤15/≤18的眼比例、无需用药的比例以及用药数量。所有时间点的安全性指标包括不良事件和二次手术。
A组术前平均IOP为14.9±3.2 mmHg，平均用药1.22±1.31种（n = 63），术后3个月平均IOP降至13.5±2.5 mmHg，平均用药0.24±0.61种（n = 34；IOP p = 0.048，用药p < 0.001）。B组术前平均IOP为16.0±4.2 mmHg，平均用药1.12±1.07种（n = 93），术后3个月平均IOP降至12.2±2.3 mmHg，平均用药0.57±1.27种（n = 23；IOP p < 0.001，用药p = 0.003）。从术前到术后3个月，A组IOP≤12 mmHg的眼比例保持在32.4%（p = 1.0），B组从21.7%升至60.9%（p = 0.0177）；A组IOP≤15 mmHg的眼比例从52.9%升至76.5%（p = 0.0963），B组从43.5%升至91.3%（p = 0.0034）。校正组间基线差异后，B组术后IOP降低幅度显著大于A组（p = 0.043）；用药减少情况相似。两组安全性均良好。
超声乳化联合iStent inject植入术，无论是否联合iAccess Precision Blade前房角切开术，均可使IOP和用药量产生具有临床意义的降低且安全性良好。与超声乳化联合iStent inject植入术相比，联合iStent inject + iAccess +超声乳化手术能实现更大幅度的IOP降低和更低的IOP阈值。本研究提供了关于这种联合术式以及新型iAccess Precision Blade的首批数据。
