Schepens Eye Research Institute of Mass Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts.
Optom Vis Sci. 2024 Jun 1;101(6):408-416. doi: 10.1097/OPX.0000000000002152.
Performance-based outcome measures are crucial for clinical trials of field expansion devices. We implemented a test simulating a real-world mobility situation, focusing on detection of a colliding pedestrian among multiple noncolliding pedestrians, suitable for measuring the effects of homonymous hemianopia and assistive devices in clinical trials.
In preparation for deploying the test in a multisite clinical trial, we conducted a pilot study to gather preliminary data on blind-side collision detection performance with multiperiscopic peripheral prisms compared with Fresnel peripheral prisms. We tested the hypothesis that detection rates for colliding pedestrians approaching on a 40° bearing angle (close to the highest collision risk when walking) would be higher with 100Δ oblique multiperiscopic (≈42° expansion) than 65Δ oblique Fresnel peripheral prisms (≈32° expansion).
Six participants with homonymous hemianopia completed the test with and without each type of prism glasses, after using them in daily mobility for a minimum of 4 weeks. The test, presented as a video on a large screen, simulated walking through a busy shopping mall. Colliding pedestrians approached from the left or the right on a bearing angle of 20 or 40°.
Overall, blind-side detection was only 23% without prisms but improved to 73% with prisms. For multiperiscopic prisms, blind-side detection was significantly higher with than without prisms at 40° (88 vs. 0%) and 20° (75 vs. 0%). For Fresnel peripheral prisms, blind-side detection rates were not significantly higher with than without prisms at 40° (38 vs. 0%) but were significantly higher with prisms at 20° (94 vs. 56%). At 40°, detection rates were significantly higher with multiperiscopic than Fresnel prisms (88 vs. 38%).
The collision detection test is suitable for evaluating the effects of hemianopia and prism glasses on collision detection, confirming its readiness to serve as the primary outcome measure in the upcoming clinical trial.
基于性能的结果测量对于场扩展设备的临床试验至关重要。我们实施了一项测试，模拟了现实世界中的移动情况，重点是检测多个非碰撞行人中的碰撞行人，适用于测量同视性偏盲和辅助设备对临床试验的影响。
为了在多地点临床试验中部署该测试，我们进行了一项初步研究，以收集使用多视场周边棱镜与菲涅尔周边棱镜相比时，同视性偏盲者对盲侧碰撞检测性能的初步数据。我们假设，在接近 40°方位角（行走时碰撞风险最高）的情况下，使用 100Δ 斜多视场（≈42°扩展）的棱镜比使用 65Δ 斜菲涅尔周边棱镜（≈32°扩展）的检测率更高。
六名同视性偏盲患者在使用每种类型的棱镜眼镜至少 4 周后，在日常活动中进行了测试。该测试以大屏幕上的视频形式呈现，模拟了在繁忙的购物中心行走。碰撞行人从左侧或右侧以 20 或 40°的方位角接近。
总体而言，不使用棱镜时盲侧检测率仅为 23%，但使用棱镜后提高到 73%。对于多视场棱镜，在 40°（88 对 0%）和 20°（75 对 0%）时，使用棱镜的盲侧检测明显高于不使用棱镜的情况。对于菲涅尔周边棱镜，在 40°时使用棱镜的盲侧检测率并不明显高于不使用棱镜的情况（38 对 0%），但在 20°时明显高于不使用棱镜的情况（94 对 56%）。在 40°时，多视场棱镜的检测率明显高于菲涅尔棱镜（88 对 38%）。
碰撞检测测试适用于评估偏盲和棱镜眼镜对碰撞检测的影响，证实其已准备好作为即将到来的临床试验中的主要结果测量。
