METHODS: Prospective, randomized, assessor-masked controlled trial at a single centre.
METHODS: Eyes with visually-significant cataract and mild-to-moderate glaucoma with preoperative intraocular pressure (IOP) of 12 to 30 mmHg on 0 to 3 ocular hypotensive medications.
METHODS: Participants eyes were randomized (2017-2020) 1:1 to combined cataract surgery with iStent Inject (treatment group, n = 56) or cataract surgery alone (control group, n = 48), and followed up for 2 years.
METHODS: The co-primary effectiveness endpoints were the number of ocular hypotensive medications and IOP at 24-months post-surgery. The secondary effectiveness endpoints were ocular comfort as measured by the Ocular Surface Disease Index (OSDI) and vision-related quality of life as measured by the Glaucoma Activity Limitation Questionnaire (GAL-9) at 24-months. Safety measures included postoperative visual acuity, any unplanned return to the operating theatre, adverse events, and complications.
RESULTS: Participants (67.3% male) were aged 53 to 85 years, and treatment groups were similar in terms of mean medicated IOP (treatment group 17.7 mmHg ± 4.0; control group 17.1 mmHg ± 3.1), and number of ocular hypotensive medications (treatment group 1.69 ± 1.05; control group 1.80 ± 1.22) at baseline. At 24 months, the number of ocular hypotensive medications were 0.7 ± 0.9 in the treatment groups compared to 1.5 ± 1.9 in the control group, with an adjusted difference of 0.6 fewer medications per eye in the treatment group (95% CI 0.2-1.1, P = 0.008). In the treatment group, 57% of eyes were on no glaucoma medications compared to 36% in the control group. There was no significant difference in IOP between the 2 groups beyond the 4-weeks. There were no differences in patient-reported outcomes between the 2 groups. The visual outcomes and safety profiles were similar between the 2 groups.
CONCLUSIONS: Combined cataract surgery with iStent Inject achieved a clinically- and statistically-significantly greater reduction in ocular hypotensive medication usage at 24-months compared to cataract surgery alone, with no significant difference in IOP.
BACKGROUND: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
方法:前瞻性,随机化,单中心的评估者蒙面对照试验。
方法:眼睛有视觉意义的白内障和轻度至中度青光眼,术前眼压(IOP)为12-30mmHg,使用0至3种眼压药物。
方法:参与者的眼睛被随机分配(2017-2020年)1:1接受白内障手术联合支架注射(治疗组,n=56)或单独进行白内障手术(对照组,n=48),并跟踪了两年。
方法:共同主要有效性终点是术后24个月时的眼压和眼压。次要有效性终点是通过眼表疾病指数(OSDI)测量的眼部舒适度和通过24个月的青光眼活动限制问卷(GAL-9)测量的与视觉相关的生活质量。安全措施包括术后视力、任何计划外的返回手术室,不良事件,和并发症。
结果:参与者(67.3%为男性)年龄在53-85岁之间,治疗组的平均药物IOP相似(治疗组17.7mmHg±4.0;对照组17.1mmHg±3.1),和基线时的低眼压药物数量(治疗组1.69±1.05;对照组1.80±1.22)。24个月时,治疗组的降眼压药物数量为0.7±0.9,而对照组为1.5±1.9,校正后的差异为治疗组的每只眼用药减少0.6(95%CI0.2~1.1,p=0.008).治疗组中57%的眼睛没有使用青光眼药物,而对照组为36%。在4周之后,两组之间的IOP没有显着差异。两组患者报告的结果没有差异。两组的视觉结果和安全性相似。
结论:与单纯白内障手术相比,联合白内障手术与iStent注射在24个月时在临床上和统计学上显著降低了眼压药物的使用。眼压无显著差异。