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基于网络的视觉功能远程监测和白内障术后自我报告结局的国际多中心随机对照试验。

Web-based telemonitoring of visual function and self-reported postoperative outcomes in cataract care: international multicenter randomized controlled trial.

机构信息

From the Department of Ophthalmology, University Medical Centre Utrecht, Utrecht, the Netherlands (Claessens, Imhof, Wisse); University Eye Clinic Maastricht, Maastricht University Medical Center+, Maastricht, the Netherlands (Wanten, Bauer, Nuijts); Oogcentrum Noordholland, Heerhugowaard, the Netherlands (Vrijman, Selek, Wouters); Department of Ophthalmology, Amphia Hospital, Breda, the Netherlands (Reus, van Dorst); Vienna Institute for Research in Ocular Surgery, a Karl Landsteiner Institute, Hanusch Hospital, Vienna, Austria (Findl, Ruiss); Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach, Germany (Boden); Mount Saint Peter Eye Clinic, Trier, Germany (Januschowski).

出版信息

J Cataract Refract Surg. 2024 Sep 1;50(9):947-955. doi: 10.1097/j.jcrs.0000000000001492.

Abstract

PURPOSE

To compare web-based, self-administered follow-up after cataract surgery to conventional face-to-face follow-up.

SETTING

Eye clinics in the Netherlands, Austria, and Germany.

DESIGN

Randomized controlled trial with an embedded method comparison study (ClinicalTrials.gov: NCT04809402).

METHODS

Routine patients with cataract were randomized into 2 groups: The telemonitoring group undertook web-based vision self-assessments and questionnaires from home, while the usual care group received conventional care. All participants had a 4- to 6-week postoperative clinic visit for safety and validation purposes. Outcomes included, the web test's accuracy for assessing postoperative visual acuity (VA) and refractive error, adverse event rates, and patient-reported outcome measurements (PROMs).

RESULTS

94 participants (188 eyes) were enrolled. Web-based uncorrected distance VA testing demonstrated a negligible mean difference (-0.03 ± 0.14 logMAR) when compared with conventional Early Treatment Diabetic Retinopathy Study chart testing, with 95% limits of agreement ranging from -0.30 to 0.24 logMAR. The web-based refraction assessment overestimated the postoperative refractive error (mean difference in spherical equivalent 0.15 ± 0.67 diopters), resulting in a poorer corrected distance VA compared with subjective refraction (mean 0.1 vs -0.1 logMAR). Rates of adverse events and unscheduled consultations were minimal across both groups. Preoperative and postoperative PROM questionnaires had a 100% response rate. Visual functioning (Catquest-9SF and National Eye Institute Visual Function Questionnaire-25) improved postoperatively (mean improvement -0.80 and 16.70, respectively) and did not significantly differ between the 2 groups.

CONCLUSIONS

The patients with cataract in this study effectively provided postoperative outcome data using a web interface. Both conventional and web-based follow-ups yielded similar PROMs and adverse event rates. Future developments should reduce the variability in the web-based VA test and yield representative refraction outcomes.

摘要

目的

比较白内障手术后基于网络的自我管理随访与传统的面对面随访。

设置

荷兰、奥地利和德国的眼科诊所。

设计

随机对照试验,嵌入方法比较研究(ClinicalTrials.gov:NCT04809402)。

方法

常规白内障患者随机分为 2 组:远程监测组在家中进行基于网络的视力自我评估和问卷调查,而常规护理组接受常规护理。所有参与者均在术后 4-6 周进行门诊检查,以确保安全性和验证目的。结果包括网络测试评估术后视力(VA)和屈光不正的准确性、不良事件发生率和患者报告的结果测量(PROMs)。

结果

共纳入 94 名患者(188 只眼)。与传统的早期糖尿病视网膜病变研究图表测试相比,基于网络的未矫正远视力测试结果显示出可忽略的平均差异(-0.03±0.14 logMAR),95%的一致性区间为-0.30 至 0.24 logMAR。基于网络的屈光评估结果高估了术后屈光不正(平均等效球镜差异 0.15±0.67 屈光度),导致矫正远视力比主观屈光更差(平均 0.1 比-0.1 logMAR)。两组的不良事件和非计划咨询发生率均较低。术前和术后 PROM 问卷的回复率均为 100%。视觉功能(Catquest-9SF 和国家眼科研究所视觉功能问卷-25)在术后均有所改善(平均改善分别为-0.80 和 16.70),两组之间无显著差异。

结论

本研究中的白内障患者通过网络界面有效地提供了术后结果数据。传统和基于网络的随访均产生了相似的 PROMs 和不良事件发生率。未来的发展应减少基于网络的 VA 测试的变异性,并获得有代表性的屈光结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d5d5/11338021/7251e1f44f64/jcrs-50-947-g001.jpg

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