Ophthalmology. Glaucoma最新文献_第4页

Mitomycin C 0.2 mg/ml versus Mitomycin C 0.4 mg/ml during the Implantation of an Ab Externo Polystyrene-isobutylene-styrene Microshunt 在植入体外 SIBS 微分流术时，0.2 毫克/毫升的丝裂霉素与 0.4 毫克/毫升的丝裂霉素：一项大型分析。

IF 2.8 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma

Pub Date : 2024-09-01 DOI: 10.1016/j.ogla.2024.06.001

Purpose

To compare the effectiveness and adverse event profile of standalone polystyrene-isobutylene-styrene (SIBS) microshunt implantation with adjunct mitomycin C (MMC) 0.2 mg/ml and MMC 0.4 mg/ml.

Design

Mega-analysis using individual patient data from international prospective and retrospective clinical studies.

Participants

Patients with glaucoma who underwent implantation of a SIBS microshunt with MMC as a standalone procedure.

Methods

A comparison of eyes that received MMC 0.2 mg/ml or 0.4 mg/ml.

Main Outcomes Measures

Primary outcome was complete success defined as the proportion of eyes at 1 year with all of the following: (1) no 2 consecutive intraocular pressures (IOPs) > 17 mmHg; (2) no clinical hypotony; (3) ≥ 20% IOP reduction from baseline; and (4) no use of glaucoma medications. Secondary outcomes included IOP thresholds of 12 mmHg, 14 mm Hg, and 21 mmHg, median IOP, number of medications, risk factors for failure, interventions, adverse events, and reoperations.

Results

At 1 year, the complete success rate was significantly higher (71.3% vs. 50.46%; P < 0.001) and the median IOP was significantly lower (13.0 vs 14.2 mmHg; P < 0.05) in the MMC 0.4 mg/ml group. Mitomycin C 0.2 mg/ml was found to be a significant risk factor for failure (hazard ratio 1.75; 95% confidence interval 1.14–2.67). Needling and surgical revision occurred at a lower rate in the MMC 0.4 mg/ml group (7% vs 18.8%; P = 0.002 and 4.3% vs 13.7% P = 0.0087, respectively). Adverse events occurred at a similar frequency in both groups (26.6% MMC 0.2 mg/ml vs 29.6% MMC 0.4 mg/ml; P = 0.46), most of which were early and transient.

Conclusion

Polystyrene-isobutylene-styrene microshunt implantation with MMC 0.4 mg/ml resulted in a higher success rate with greater IOP reduction compared with MMC 0.2 mg/ml. Higher MMC concentration was not associated with increased serious adverse events.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的：比较独立SIBS微分流植入术与辅助MMC 0.2 mg/ml和MMC 0.4 mg/ml的有效性和不良事件概况：设计：利用国际前瞻性和回顾性临床研究中的单个患者数据进行大规模分析：研究对象：接受SIBS微分流术并将MMC作为独立手术植入的青光眼患者：主要结果测量：主要结果是完全成功，定义为一年后具备以下所有条件的眼睛比例：(1)无连续两次眼压>17 mmHg；(2)无临床低眼压症状；(3)眼压较基线下降≥20%；(4)未使用青光眼药物。次要结果包括 12 毫米汞柱、14 毫米汞柱和 21 毫米汞柱的眼压阈值、中位眼压、用药次数、失败的风险因素、干预措施、不良事件和再次手术：结果：1 年后的完全成功率明显更高（71.3% 对 50.46%，P=0.05）：与 MMC 0.2 mg/ml 相比，使用 MMC 0.4 mg/ml 植入 SIBS 微分流术的成功率更高，眼压降低幅度更大。较高浓度的 MMC 与严重不良事件的增加无关。

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引用次数: 0

Comparison of a Novel Head-Mounted Objective Auto-perimetry (Gaze Analyzing Perimeter) and Humphrey Field Analyzer 新型头戴式客观自动测距仪（注视分析周长）与汉弗莱视场分析仪的比较。

IF 2.8 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma

Pub Date : 2024-09-01 DOI: 10.1016/j.ogla.2024.05.003

Purpose

To evaluate the agreement between 24-2 visual field (VF) test results obtained using the gaze analyzing perimeter (GAP; Findex) and the Humphrey field analyzer (HFA; Carl Zeiss Meditec).

Design

Cross-sectional study.

Participants

Patients underwent HFA 24-2 for suspected or confirmed VF loss and were treated at the Kyoto University Hospital between December 2022 and July 2023.

Methods

Patients underwent consecutive VF tests on the same eye using HFA and GAP 24-2 tests. Bland–Altman analysis was used to compare GAP and HFA results. Examination points where the sensitivity measured using GAP was ≥ 10 dB higher than that measured using HFA were re-evaluated by referring back to the original gaze data; 2 ophthalmologists assessed whether the gaze moved linearly toward the new test target.

Main Outcome Measures

Mean deviation (MD) and elapsed time on an individual basis and sensitivity on an examination point basis.

Results

Forty-seven eyes of 47 patients were analyzed. The correlation coefficient of the MD using HFA and GAP was 0.811 (95% confidence interval [CI]: 0.683–0.891). Bland–Altman analysis showed good agreement between HFA and GAP tests. The mean difference (95% limits of agreement) in MD between HFA and GAP results was −0.63 dB (−5.81 to 4.54 dB). Although no statistically significant differences were observed in the elapsed time (P = 0.99), measurements completed within 200 seconds were observed only in the GAP group (11 cases, 23.4%), who had significantly better HFA MD value than others (P = 0.001). On an examination point basis for sensitivity, the correlation coefficient between HFA and GAP was 0.691 (95% limits of agreement, 0.670–0.711). Original gaze data assessment revealed that the gaze moved linearly toward the new test target for 70.2% of the examination points with a sensitivity discrepancy.

Conclusions

The results indicate that the GAP provides VF assessment outcomes comparable to those of the HFA. The GAP exhibited advantages in terms of testing time, particularly in patients with minimal VF impairment. Furthermore, the GAP records all eye movements, enabling the objective determination of VF abnormalities based on gaze patterns and facilitating easy posthoc verification.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的：评估使用凝视分析仪（GAP；FINDEX，日本东京）和汉弗莱视野分析仪（HFA；卡尔蔡司医疗技术公司，美国加利福尼亚州都柏林）获得的 24-2 视野（VF）测试结果之间的一致性：设计：横断面研究参与者：2022 年 12 月至 2023 年 7 月期间在京都大学医院接受治疗的疑似或确诊 VF 缺失的 HFA 24-2 患者：患者使用 HFA 和 GAP 24-2 测试对同一只眼睛进行连续 VF 测试。使用 Bland-Altman 分析比较 GAP 和 HFA 的结果。对使用 GAP 测得的灵敏度比使用 HFA 测得的灵敏度高≥10 dB 的检查点，通过回溯原始注视数据进行重新评估；由两名眼科医生评估注视是否向新的测试目标线性移动：主要结果测量指标：以个体为单位的平均偏差（MD）和耗时，以及以检查点为单位的灵敏度：对 47 名患者的 47 只眼睛进行了分析。使用 HFA 和 GAP 的 MD 相关系数为 0.811（95% 置信区间 [CI]：0.683-0.891）。Bland-Altman分析表明，HFA和GAP测试之间具有良好的一致性。HFA 和 GAP 结果的 MD 平均差异（95% 置信区间 [LOA]）为 -0.63 dB（-5.81 至 4.54 dB）。虽然在所用时间上没有观察到明显的统计学差异（P = 0.99），但只有 GAP 组（11 例，23.4%）的测量在 200 秒内完成，他们的 HFA MD 值明显优于其他组（P=0.001）。根据检查点的敏感性，HFA 和 GAP 之间的相关系数为 0.691（95% LOA，0.670-0.711）。原始凝视数据评估显示，70.2%的检查点的凝视呈线性向新的测试目标移动，存在灵敏度差异：结果表明，GAP 可提供与 HFA 相当的 VF 评估结果。GAP 在测试时间方面表现出优势，尤其是对视力损害极小的患者。此外，GAP 还能记录所有眼球运动，从而能根据注视模式客观判断 VF 异常，便于事后验证。

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引用次数: 0

Glucagon-Like Peptide 1 Receptor Agonists: A Role in Glaucoma? 胰高血糖素样肽 1 受体激动剂：在青光眼中的作用？

IF 2.8 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma

Pub Date : 2024-09-01 DOI: 10.1016/j.ogla.2024.03.005

引用次数: 0

Publication Rate of Abstracts Presented at American Glaucoma Society Annual Meetings 在美国青光眼协会年会上提交的摘要的发表率。

IF 2.8 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma

Pub Date : 2024-09-01 DOI: 10.1016/j.ogla.2024.05.001

引用次数: 0

Hidden Depths of Glaucomatous Disc 青光眼椎间盘的隐藏深度

IF 2.8 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma

Pub Date : 2024-09-01 DOI: 10.1016/j.ogla.2024.03.001

引用次数: 0

Starstruck Lens: Iatrogenic Rosette Cataract and Its Spontaneous Resolution 追星透镜：先天性玫瑰型白内障及其自然消退。

IF 2.8 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma

Pub Date : 2024-09-01 DOI: 10.1016/j.ogla.2024.02.006

引用次数: 0

Comparison of Peripapillary Choroidal Thickness Between Primary Open-angle Glaucoma, Normal Tension Glaucoma, and Normal Eyes 原发性开角型青光眼、正常张力性青光眼和正常眼毛细血管周围厚度的比较：系统回顾和元分析。

IF 2.8 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma

Pub Date : 2024-07-01 DOI: 10.1016/j.ogla.2024.02.008

Topic

To investigate differences in peripapillary choroidal thickness (PPCT) between primary open-angle glaucoma (POAG), normal tension glaucoma (NTG), and healthy eyes, additionally comparing differences between POAG and NTG eyes.

Clinical Relevance

Peripapillary choroidal thickness is a well-established OCT parameter in eyes with glaucoma and other ocular pathologies. The relationship between PPCT and glaucoma, if better understood, may facilitate the development of PPCT as a potential diagnostic and monitoring metric for glaucoma. In particular, there has yet to be a synthesis that directly compares PPCT between POAG eyes and NTG eyes.

Methods

A comprehensive literature search was performed on PubMed, EMBASE, and Cochrane Library, identifying studies from inception to December 2022. We included studies that measured PPCT using OCT in POAG, NTG, and healthy eyes. Mean difference (MD) among groups was calculated. Statistical analysis was performed using R version 4.2.0. Risk of bias of included studies was assessed using the Newcastle Ottawa Scale (NOS).

Results

Eighteen studies were included in this meta-analysis, with a pooled total of 935 healthy control eyes, 446 NTG eyes, and 934 POAG eyes. There was a significant reduction of PPCT in POAG eyes compared with healthy eyes [MD = −16.32; 95% confidence interval (CI) (−27.55 to −5.09)]. Reduction in PPCT was also significant in NTG eyes compared with healthy eyes [MD = −34.96; 95% CI (−49.97 to −19.95)]. NTG eyes had significantly reduced PPCT compared with POAG eyes [MD = −26.64; 95% CI (−49.00 to −4.28)].

Conclusions

Glaucomatous eyes appear to have significantly reduced PPCT compared with normal healthy eyes. In addition, PPCT in NTG eyes appear significantly thinner compared with that in POAG eyes.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

主题研究原发性开角型青光眼（POAG）、正常张力青光眼（NTG）和健康眼之间毛细血管周围脉络膜厚度（PPCT）的差异，并比较POAG和NTG眼之间的差异：毛细血管周围脉络膜厚度（PPCT）是青光眼和其他眼部病变中一个成熟的光学相干断层扫描（OCT）参数。如果能更好地了解 PPCT 与青光眼之间的关系，将有助于将 PPCT 发展成为一种潜在的青光眼诊断和监测指标。特别是，目前还没有直接比较POAG眼和NTG眼的PPCT的综述：在 PubMed、EMBASE 和 Cochrane Library 上进行了全面的文献检索，确定了从开始到 2022 年 12 月的研究。我们纳入了使用光学相干断层扫描（OCT）测量 POAG、NTG 和健康眼 PPCT 的研究。计算各组间的平均差（MD）。统计分析使用 R 4.2.0 版本进行。采用纽卡斯尔-渥太华量表（NOS）对纳入研究的偏倚风险进行评估：本次荟萃分析共纳入了 18 项研究，汇总了 935 只健康对照眼、446 只 NTG 眼和 934 只 POAG 眼。与健康眼相比，POAG 眼的 PPCT 明显下降[MD = -16.32，95% CI (-27.55, -5.09)]。与健康眼睛相比，NTG 眼睛的 PPCT 也有显著降低[MD = -34.96，95% CI (-49.97, -19.95)]。与POAG眼相比，NTG眼的PPCT明显降低[MD = -26.64，95% CI (-49.00, -4.28)]：结论：与正常健康眼相比，青光眼眼的 PPCT 明显降低。结论：与正常健康眼睛相比，青光眼患者眼睛的 PPCT 明显减少。此外，与 POAG 眼睛相比，NTG 眼睛的 PPCT 明显变薄。

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引用次数: 0

A Comparative Analysis of Intraocular Pressure Measurement Accuracy With Reused iCare Probes 使用重复使用的 iCare 探头进行眼压测量准确性对比分析。

IF 2.8 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma

Pub Date : 2024-07-01 DOI: 10.1016/j.ogla.2024.02.005

Purpose

To assess the accuracy of reused iCare probes after disinfection with 70% isopropyl alcohol and ethylene oxide gas compared to new iCare probes and Goldmann applanation tonometry (GAT).

Design

Prospective comparative analysis.

Participants

A total of 118 eyes from 59 patients recruited from the Aravind Eye Hospital glaucoma clinic in Tirupati, South India.

Methods

Intraocular pressure (IOP) was measured on each eye using a new iCare tonometer probe, an iCare probe previously used and disinfected 1 time prior (once used probe) and 5 times prior (multiply used probe), as well as with GAT. Probes were disinfected after each use with 70% isopropyl alcohol swabs and ethylene oxide sterilization.

Main Outcome Measures

Agreement demonstrated with intraclass correlation coefficients (ICCs), mean difference in IOP values with limits of agreement, and Bland-Altman plots among IOP measurement approaches.

Results

Compared to new iCare probes, both once used probes (ICC = 0.989, 95% confidence interval [CI] 0.985–0.993) and multiply used probes (ICC = 0.989, 95% CI 0.984–0.992) showed excellent agreement, and the mean difference in IOP was minimal for both once used probes (0.70 mmHg, 95% CI 0.29–1.11) and multiply used probes (0.75 mmHg, 95% CI 0.66–0.82) compared to new probes. Bland-Altman plots demonstrated minimal differences between new and reused probes across the spectrum of IOP. When comparing multiply used probes to once used probes, there was a high level of agreement (0.993) (95% CI 0.990–0.995) and negligible mean IOP difference 0.04 mmHg (95% CI 0.32–0.40). Additionally, ICC values for new probes (0.966, 95% CI 0.951–0.976), once used probes (0.958, 95% CI 0.940–0.971), and multiply used probes (0.957, 95% CI 0.938–0.970) compared to GAT were similar and all showed excellent agreement. Both new and reused iCare probes underestimated IOP by 2 to 3 mmHg compared to GAT.

Conclusions

In this prospective comparative analysis, we found that reusing iCare probes up to 5 times does not compromise the accuracy of IOP measurements when disinfected with 70% isopropyl alcohol swabs and ethylene oxide. Reusing iCare probes has the potential to transform care by reducing cost, decreasing environmental waste, and allowing for glaucoma screening camps and increased glaucoma monitoring in low resource settings leading to earlier identification and treatment of glaucoma.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的评估经 70% 异丙醇和乙二醇消毒后重复使用的 iCare 探针与新 iCare 探针和戈德曼眼压计 (GAT) 相比的准确性：前瞻性比较分析参与者：从印度南部蒂鲁帕蒂的 Aravind 眼科医院青光眼诊所招募的 59 名患者的 118 只眼睛：使用新的 iCare 眼压计探头、之前使用过并消毒过一次（使用过一次的探头）和五次（使用过多次的探头）的 iCare 探头以及 GAT 测量每只眼睛的眼压。探针每次使用后都用 70% 异丙醇棉签消毒，并用环氧乙烷灭菌：主要结果测量：通过类内相关系数（ICC）、眼压值的平均差异与一致性极限以及眼压测量方法之间的布兰-阿尔特曼图显示一致性：与新的 iCare 探头相比，一次性使用的探头（ICC=0.989，95%CI 0.985-0.993）和多次使用的探头（ICC=0.989，95%CI 0.984-0.992）显示出极好的一致性，与新探头相比，一次性使用的探头（0.70 mmHg，95%CI 0.29-1.11）和多次使用的探头（0.75 mmHg，95%CI 0.66-0.82）的眼压平均差极小。Bland-Altman 图显示，在整个 IOP 范围内，新探针和重复使用探针之间的差异极小。在比较多次使用的探针和一次使用的探针时，两者的一致性很高（0.993（95%CI 0.990-0.995）），平均 IOP 差异为 0.04 mmHg（95%CI -0.32-0.40），可以忽略不计。此外，与 GAT 相比，新探针（0.966，95%CI 0.951-0.976）、使用过一次的探针（0.958，95%CI 0.940-0.971）和多次使用的探针（0.957，95%CI 0.938-0.970）的 ICC 值相似，都显示出极好的一致性。与 GAT 相比，新的和重复使用的 iCare 探头都低估了 2-3 mmHg 的眼压：在这项前瞻性比较分析中，我们发现重复使用 iCare 探头多达五次并不会影响用 70% 异丙醇棉签和环氧乙烷消毒后测量眼压的准确性。重复使用 iCare 探头有可能通过降低成本、减少环境废物、在资源匮乏的环境中开展青光眼筛查营和增加青光眼监测来改变医疗服务，从而尽早发现和治疗青光眼。

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引用次数: 0

Incidence and Outcomes of Hypertensive Phase After Glaucoma Drainage Device Surgery 青光眼引流装置手术后高血压期的发生率和结果。

IF 2.8 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma

Pub Date : 2024-07-01 DOI: 10.1016/j.ogla.2024.03.006

Purpose

To describe the incidence, risk factors, clinical characteristics, and long-term outcomes of a hypertensive phase (HP) after glaucoma drainage device (GDD) implantation.

Design

Retrospective cohort study.

Participants

Eyes that underwent implantation of their first GDD from January 2010 to October 2020 at a tertiary care center.

Methods

Hypertensive phase was defined as intraocular pressure (IOP) >21 mmHg occurring at 2 consecutive visits in the first 90 days after the date of surgery for Ahmed Glaucoma Valve (AGV) or in the first 90 days after tube opening for Baerveldt Glaucoma Implant (BGI). Generalized estimating equations and Fisher exact tests were used to evaluate risk factors for HP and risk factors for failure of GDD surgery after occurrence of a HP.

Main Outcome Measures

Incidence and risk factors for HP. Overall surgical success rates, defined as the absence of failure criteria: IOP >21 mmHg, ≤5 mmHg, or <20% reduction below baseline IOP after 3 months for 2 consecutive visits, with or without adjunctive ocular hypotensive therapy; additional glaucoma surgery; or loss of light perception.

Results

Among 419 eyes of 360 patients that underwent GDD implantation, 42 (10.0%) eyes developed HP. Onset of HP was 20.8 ± 10.5 days after AGV and 11.7 ± 20.3 days from the date of tube opening after BGI. Mean IOP during HP was 26.5 ± 3.2 mmHg with peak IOP of 30.0 ± 5.9 mmHg. Median follow-up duration was 21.5 months after onset of HP. Younger age and neovascular glaucoma were significant risk factors for HP occurrence in a multivariable model. Resolution of HP occurred in 32 eyes (76.2%) after a mean duration of 48.0 ± 53.0 days. Additional surgery with a second GDD or cyclophotocoagulation was performed for 12 eyes (28.6%). The overall success rate among eyes with a HP was 52.6% at 2 years, which was significantly lower than that observed among control eyes that did not experience HP (76.3%), P < 0.01.

Conclusions

The incidence of HP was 10.0%. Younger age and neovascular glaucoma were significant risk factors for HP in the multivariable model. The risk of surgical failure after HP is significantly higher compared to eyes that did not experience HP.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的：描述青光眼引流装置（GDD）植入后高血压期（HP）的发生率、风险因素、临床特征和长期预后：设计：回顾性队列研究：方法：Ahmed青光眼瓣膜（AGV）手术后90天内或Baerveldt青光眼植入器（BGI）开管后90天内，连续2次就诊时眼压（IOP）>21 mmHg即为高血压期。使用广义估计方程和费雪精确检验来评估HP的风险因素和发生HP后GDD手术失败的风险因素：主要结果指标：HP的发生率和风险因素。手术总成功率，定义为无失败标准：眼压>21 mmHg、≤5 mmHg或结果：在接受 GDD 植入术的 360 名患者的 419 只眼睛中，有 42 只眼睛（10.0%）出现了 HP。Ahmed青光眼瓣膜植入术后20.8±10.5天、Baerveldt植入术后11.7±20.3天（从开管之日起算）出现HP。HP期间的平均眼压为26.5±3.2 mmHg，峰值眼压为30.0±5.9 mmHg。中位随访时间为 HP 开始后 21.5 个月。在多变量模型中，年龄较小和新生血管性青光眼是HP发生的重要风险因素。32只眼睛（76.2%）的HP在平均持续48.0±53.0天后得到缓解。有 12 只眼睛（28.6%）接受了第二次 GDD 或环形光凝的额外手术。2年后，HP眼的总体成功率为52.6%，明显低于未发生HP的对照眼（76.3%），PConclusions：HP的发生率为10.0%。在多变量模型中，年轻和新生血管性青光眼是HP的重要风险因素。与未经历过HP的眼睛相比，HP后手术失败的风险明显更高。

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引用次数: 0

Prospective, Randomized Controlled Trial of Cataract Surgery vs Combined Cataract Surgery With Insertion of iStent Inject 白内障手术与植入 iStent 注射器的白内障联合手术的前瞻性随机对照试验。

IF 2.8 Q1 OPHTHALMOLOGY

Ophthalmology. Glaucoma

Pub Date : 2024-07-01 DOI: 10.1016/j.ogla.2024.02.004

Purpose

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.

Design

Prospective, randomized, assessor-masked controlled trial at a single centre.

Participants

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.

Main Outcome Measures

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.

Financial Disclosure(s)

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

目的：评估对轻度至中度青光眼患者进行白内障手术与植入小梁微搭桥装置（iStent Inject，Glaukos 公司）的联合手术与单纯白内障手术的疗效和安全性：设计：在一个中心进行的前瞻性、随机、评估者掩蔽对照试验：术前眼压（IOP）为12 - 30 mmHg，使用0至3种降压药物的视力明显白内障和轻度至中度青光眼患者：将参与者的眼睛按1:1随机分配（2017-2020年）至联合白内障手术与iStent Inject（治疗组，n=56）或单纯白内障手术（对照组，n=48），并随访两年：共同主要疗效终点为手术后24个月的降眼压药物使用次数和眼压。次要有效性终点是眼表疾病指数（OSDI）测量的眼部舒适度和24个月时青光眼活动限制问卷（GAL-9）测量的视力相关生活质量。安全性指标包括术后视力、任何意外返回手术室、不良事件和并发症：基线时，治疗组的平均药物治疗眼压（治疗组 17.7 mmHg ± 4.0；对照组 17.1 mmHg ± 3.1）和降眼压药物数量（治疗组 1.69 ± 1.05；对照组 1.80 ± 1.22）相似。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，调整后治疗组每只眼睛的降眼压药物数量减少了 0.6（95% CI 0.2 至 1.1，P=0.008）。治疗组有 57% 的眼睛没有服用青光眼药物，而对照组只有 36%。4 周后，两组患者的眼压无明显差异。两组患者报告的疗效无差异。两组的视觉效果和安全性相似：结论：与单纯白内障手术相比，联合白内障手术和 iStent Inject 在 24 个月时可显著减少降眼压药物的使用量，在临床和统计学上都有显著意义，但眼压没有明显差异。

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引用次数: 0