Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Department of Ophthalmology, Case Western Reserve University, Cleveland, Ohio, USA.
Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA; Moorfields Eye Hospital, London, United Kingdom; Department of Ophthalmology, Johannes Kepler Universität, Linz, Austria; Department of Ophthalmology, Medizinische Universität Graz, Graz, Austria.
Am J Ophthalmol. 2020 Sep;217:305-316. doi: 10.1016/j.ajo.2020.05.002. Epub 2020 May 11.
Sensitive, reproducible visual function biomarkers are necessary to evaluate the efficacy of emerging treatments for Stargardt disease type 1 in clinical trials. We previously demonstrated that fixation stability may serve as a secondary outcome parameter for visual function loss. However, the test duration and protocol have an unknown effect on the assessment of fixation stability. Here, we hypothesize that separate fixation testing with a single target is different from combined fixation testing using the same target with simultaneous perimetry testing.
International, multicenter, prospective, cross-sectional study.
Microperimetry data from the international, multicenter, prospective Progression of Atrophy Secondary to Stargardt Disease (ProgStar, NCT01977846) study were analyzed. Patients underwent various types of fixation testing including static testing and dynamic testing, and a duration-corrected dynamic test was generated (30sEpoch).
A total of 437 eyes from 235 patients were included (mean age, 33.8 ± 15.1 years; 55.3% female). The mean 1SD-BCEA (bivariate contour ellipse area), which is the smallest ellipse encompassing 1 standard deviation of all fixation events, was smaller for the static fixation test compared to the 30sEpoch (4.5 ± 6.9 deg vs 5.3 ± 7.0 deg; P = .02) and the number of points within both the 2-degree and 4-degree circles was larger (P < .0001).
Our results suggest that differences in static and dynamic assessment of fixation stability are dependent not only on different test durations but also on the testing protocol of a single fixation target vs fixation target plus simultaneous perimetry testing and provide information on the conduct of fixation testing for clinical trials.
在临床试验中，需要灵敏且可重复的视觉功能生物标志物来评估新兴治疗方法对 1 型斯塔加特病的疗效。我们之前已经证明，固视稳定性可以作为视觉功能丧失的次要终点参数。然而，测试时长和方案对固视稳定性的评估具有未知的影响。在这里，我们假设使用单个目标进行单独的固视测试与使用相同目标同时进行的固视和周边视野测试不同。
国际多中心前瞻性横断面研究。
对国际多中心前瞻性斯塔加特病萎缩进展研究（ProgStar，NCT01977846）的微视野数据进行了分析。患者接受了各种类型的固视测试，包括静态测试和动态测试，并生成了时长校正的动态测试（30sEpoch）。
共纳入 235 例患者的 437 只眼（平均年龄 33.8 ± 15.1 岁；55.3%为女性）。最小包含所有固视事件 1 个标准差的双变量轮廓椭圆面积（1SD-BCEA）的平均值在静态固视测试中小于 30sEpoch（4.5 ± 6.9 度比 5.3 ± 7.0 度；P =.02），且在 2 度和 4 度圈内的点数也更多（P <.0001）。
我们的结果表明，静态和动态评估固视稳定性的差异不仅取决于不同的测试时长，还取决于单个固视目标与固视目标加同时周边视野测试的测试方案，为临床试验中的固视测试提供了信息。
