Abstract：
OBJECTIVE: To evaluate the efficacy and safety of combined cataract surgery with insertion of an ab interno trabecular microbypass device (iStent Inject, Glaukos Corporation) compared to cataract surgery alone in patients with mild-to-moderate glaucoma.
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.
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.
摘要：
目的：评估联合白内障手术的有效性和安全性，并插入ab间小梁微旁路装置（iStentInject，GlaukosCorporation）与轻度至中度青光眼患者的单独白内障手术相比。
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。
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。
