目的:为了评估密集,在Fast-PACE(通过聚类评估的进展评估)研究中,聚类测试方法可识别超过6个月的快速青光眼进展的眼睛。
方法:前瞻性队列研究。
方法:来自65名原发性开角型青光眼(POAG)受试者的125只眼。
方法:受试者进行了两组每周5次的访问(集群),平均间隔6个月,随后每6个月进行一次访视,总体平均随访25个月(平均17次测试).每次访问包括使用标准自动视野(SAP)24-2和10-2以及光谱域光学相干断层扫描(SDOCT)进行测试。使用SAP平均偏差(MD)和视网膜神经纤维层(RNFL)厚度的趋势分析评估进展。应用广义估计方程来调整眼睛之间的相关性,以进行置信区间(CI)估计和假设检验。
方法:6个月聚类期的诊断准确性,以识别在总体随访期间检测到的进展。
结果:125眼的19眼(15%,CI:9%-24%)在6个月的集群期内基于SAP24-2MD进展。14只眼睛(11%,CI:6%-20%)在SAP10-2MD上进展,和16(13%,CI:8%-21%)按RNFL厚度计算,125只眼睛中有30只(24%,CI:16%-34%)按功能进展,结构,或者两者兼而有之。在整个随访期间,35只眼睛进展,25在6个月的聚类期内取得了进展,敏感性为71%(CI:53%-85%)。在整个随访期间没有进展的90只眼睛中,85在6个月期间也没有进展,特异性为94%(CI:88%-98%)。在整个随访期间,通过SAP24-2、10-2或SDOCT被认为是快速进展的14只眼睛中,13个被确定为在6个月的集群期间取得进展,对于识别快速进展的敏感性为93%(CI:66%-100%),特异性为85%(CI:77%-90%)。
结论:在Fast-PACE研究中进行的聚类检测在6个月内发现了快速进展的青光眼。该方法可应用于临床试验,研究减缓青光眼进展的干预措施,也可能对高风险受试者的短期评估有价值。
OBJECTIVE: 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.
METHODS: Prospective cohort
study.
METHODS: A total of 125 eyes from 65 primary open-angle glaucoma (POAG) subjects.
METHODS: 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.
METHODS: Diagnostic accuracy of the 6-month clustering period to identify progression detected during the overall follow-up.
RESULTS: 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%).
CONCLUSIONS: 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.
BACKGROUND: Proprietary or commercial disclosure may be found after the references in the Footnotes and Disclosures at the end of this article.