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首页> 外文期刊>Investigative ophthalmology & visual science >Converting to SITA-Standard from Full-Threshold Visual Field Testing in the Follow-up Phase of a Clinical Trial.
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Converting to SITA-Standard from Full-Threshold Visual Field Testing in the Follow-up Phase of a Clinical Trial.

机译:在临床试验的后续阶段,从全阈值视野测试转换为SITA标准。

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PURPOSE: To evaluate the impact of converting from Humphrey 24-2 full-threshold (FT) visual field (VF) testing to SITA-Standard (SS) VF testing during the follow-up phase of a clinical trial. METHODS: VF data were obtained from 243 patients in the Collaborative Initial Glaucoma Treatment Study (CIGTS) who had follow-up visits in 2004. FT and SS VF tests were performed in random order on the same day. RESULTS: The average duration of the SS test (6.3 minutes) was shorter (P < 0.0001, paired t-test) than the FT test (11.8 minutes). The mean deviation did not differ between SS and FT testing. A small difference was found in the pattern SD (PSD) (P = 0.02). The mean CIGTS score from the FT test (4.5) was significantly lower (P < 0.0001) than the mean CIGTS score from the SS test (6.0). Although the two tests yielded identical Glaucoma Hemifield Test (GHT) results in 179 patients (76%), 16 patients had a normal GHT result on FT testing and an SS test result that was outside normal limits. Six patients had the reverse finding. The most significant factor associated with an increased (positive) difference between the CIGTS VF score generated from SS and FT testing was conducting the FT test first (P < 0.0001). CONCLUSIONS: Although SS and FT testing yielded very similar mean deviation results, the CIGTS VF score and GHT differed between SS and FT tests. Changing the approach used to measuring a study's primary VF outcome should be accompanied by a critical evaluation of the change's impact.
机译:目的:在临床试验的后续阶段,评估从汉弗莱24-2全阈值(FT)视野(VF)测试转换为SITA标准(SS)VF测试的影响。方法:VF数据来自于2004年在初始青光眼合作治疗研究(CIGTS)中进行随访的243例患者。FT和SS VF测试在当天随机进行。结果:SS测试的平均持续时间(6.3分钟)比FT测试(11.8分钟)短(P <0.0001,配对t检验)。 SS和FT测试之间的平均偏差没有差异。发现模式SD(PSD)的差异很小(P = 0.02)。 FT测试的平均CIGTS得分(4.5)显着低于SS测试的平均CIGTS得分(6.0)(P <0.0001)。尽管这两种测试在179例患者中获得了相同的青光眼半视野测试(GHT)结果(76%),但是16例患者的FT测试GHT结果正常且SS测试结果超出正常范围。六名患者有相反的发现。与从SS和FT测试生成的CIGTS VF评分增加(正)差异相关的最重要因素是首先进行FT测试(P <0.0001)。结论:尽管SS和FT测试得出的平均偏差结果非常相似,但CIGTS VF评分和GHT在SS和FT测试之间有所不同。更改用于衡量研究的主要VF结果的方法时,应伴有对更改影响的严格评估。

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