Medeiros Felipe A, Malek Davina A, Tseng Henry, Swaminathan Swarup S, Boland Michael V, Friedman David S, Jammal Alessandro A
Bascom Palmer Eye Institute, University of Miami, Miami, Florida; Duke Eye Center and Department of Ophthalmology, Duke University, Durham, North Carolina.
Bascom Palmer Eye Institute, University of Miami, Miami, Florida.
Ophthalmology. 2024 Jun;131(6):645-657. doi: 10.1016/j.ophtha.2023.12.031. Epub 2023 Dec 29.
To evaluate the performance of an intensive, clustered testing approach in identifying eyes with rapid glaucoma progression over 6 months in the Fast Progression Assessment through Clustered Evaluation (Fast-PACE) Study.
Prospective cohort study.
A total of 125 eyes from 65 primary open-angle glaucoma (POAG) subjects.
Subjects underwent 2 sets of 5 weekly visits (clusters) separated by an average of 6 months and then were followed with single visits every 6 months for an overall mean follow-up of 25 months (mean of 17 tests). Each visit consisted of testing with standard automated perimetry (SAP) 24-2 and 10-2, and spectral-domain OCT (SD-OCT). Progression was assessed using trend analyses of SAP mean deviation (MD) and retinal nerve fiber layer (RNFL) thickness. Generalized estimating equations were applied to adjust for correlations between eyes for confidence interval (CI) estimation and hypothesis testing.
Diagnostic accuracy of the 6-month clustering period to identify progression detected during the overall follow-up.
A total of 19 of 125 eyes (15%, CI, 9%-24%) progressed based on SAP 24-2 MD over the 6-month clustering period. A total of 14 eyes (11%, CI, 6%-20%) progressed on SAP 10-2 MD, and 16 eyes (13%, CI, 8%-21%) progressed by RNFL thickness, with 30 of 125 eyes (24%, CI, 16%-34%) progressing by function, structure, or both. Of the 35 eyes progressing during the overall follow-up, 25 had progressed during the 6-month clustering period, for a sensitivity of 71% (CI, 53%-85%). Of the 90 eyes that did not progress during the overall follow-up, 85 also did not progress during the 6-month period, for a specificity of 94% (CI, 88%-98%). Of the 14 eyes considered fast progressors by SAP 24-2, SAP 10-2, or SD-OCT during the overall follow-up, 13 were identified as progressing during the 6-month cluster period, for a sensitivity of 93% (CI, 66%-100%) for identifying fast progression with a specificity of 85% (CI, 77%-90%).
Clustered testing in the Fast-PACE Study detected fast-progressing glaucoma eyes over 6 months. The methodology could be applied in clinical trials investigating interventions to slow glaucoma progression and may be of value for short-term assessment of high-risk subjects.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article.
在通过聚类评估进行快速进展评估（Fast-PACE）研究中，评估一种密集的聚类检测方法在识别6个月内青光眼快速进展眼方面的性能。
前瞻性队列研究。
来自65例原发性开角型青光眼（POAG）受试者的125只眼。
受试者接受2组每周5次的就诊（聚类），平均间隔6个月，然后每6个月进行单次就诊，总体平均随访25个月（平均17次检查）。每次就诊包括使用标准自动视野计（SAP）24-2和10-2以及光谱域光学相干断层扫描（SD-OCT）进行检测。使用SAP平均偏差（MD）和视网膜神经纤维层（RNFL）厚度的趋势分析来评估进展情况。应用广义估计方程来调整眼间相关性，以进行置信区间（CI）估计和假设检验。
6个月聚类期识别总体随访期间检测到的进展的诊断准确性。
在6个月聚类期内，基于SAP 24-2 MD，125只眼中共有19只（15%，CI，9%-24%）进展。基于SAP 10-2 MD有14只眼（11%，CI，6%-20%）进展，基于RNFL厚度有16只眼（13%，CI，8%-21%）进展，125只眼中有30只（24%，CI，16%-34%）在功能、结构或两者方面进展。在总体随访期间进展的35只眼中，25只在6个月聚类期内进展，敏感性为71%（CI，53%-85%）。在总体随访期间未进展的90只眼中，85只在6个月期间也未进展，特异性为94%（CI，88%-98%）。在总体随访期间被SAP 24-2、SAP 10-2或SD-OCT视为快速进展者的14只眼中，13只在6个月聚类期内被识别为进展，识别快速进展的敏感性为93%（CI，66%-100%），特异性为85%（CI，77%-90%）。
Fast-PACE研究中的聚类检测在6个月内检测到了青光眼快速进展眼。该方法可应用于研究减缓青光眼进展干预措施的临床试验，可能对高危受试者的短期评估有价值。
在本文末尾的脚注和披露中的参考文献之后可能会发现专有或商业披露。
