Purpose

This study determines the short-term compliance to regular home monitoring of macular retinal sensitivity (RS) in intermediate age-related macular degeneration (iAMD). We also compare home-based outcomes with in-clinic outcomes determined using 1. the same tablet device under supervision and 2. the Macular Integrity Assessment (MaIA) microperimeter.

Design

Single-centre longitudinal compliance and reliability study.

Methods

Seventy-three participants with iAMD were trained to perform macular field testing with the Melbourne Rapid Fields-macular (MRF-m) iPad application. Volunteers were asked to retur 6 weekly tests from home, guided by audio instructions. We determined compliance to weekly testing and surveyed for factors that limited compliance. Test reliability (false positive, false negative) and retinal sensitivity (RS) were compared to in-clinic assays (MaIA). Data are shown as mean ±[standard deviation] or median[quartile 1-3 range]. Group comparisons were achieved with bootstrap to define the 95% confidence limits.

Results

Fifty-nine participants submitted 6 home exams with a median inter-test interval of 8.0 [7.0–17] days. Compliance to weekly testing (7 days ±24 hours) was 55%. The main barrier to compliance was IT logistic reasons. Of 694 home exams submitted, 96% were reliable (FP<25%). The mean RS returned by the tablet was significantly higher (+3.2 dB, p<0.05) compared to the MaIA.

Conclusions

Home monitoring produces reliable results that differ from in-clinic tests due to test design. This should not impact self-monitoring once an at-home baseline is established, but these differences will affect comparisons to in-clinic outcomes. Reasonable compliance to weekly testing was achieved. Improved IT support might lead to better compliance.

中文翻译：

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基于平板电脑的家庭监测年龄相关性黄斑变性临床测试的短期依从性和一致性

目的

本研究确定了在中度年龄相关性黄斑变性 (iAMD) 中对黄斑视网膜敏感性 (RS) 进行定期家庭监测的短期依从性。我们还将家庭结果与使用 1. 受监督的相同平板设备和 2. 黄斑完整性评估 (MaIA) 微周长确定的临床结果进行比较。

设计

单中心纵向顺应性和可靠性研究。

方法

73 名 iAMD 参与者接受了使用墨尔本快速黄斑 (MRF-m) iPad 应用程序进行黄斑现场测试的培训。志愿者被要求在语音指导的指导下在家中进行 6 次每周测试。我们确定了每周测试的合规性，并调查了限制合规性的因素。将测试可靠性（假阳性、假阴性）和视网膜敏感性（RS）与临床试验（MaIA）进行了比较。数据显示为平均值±[标准偏差]或中位数[四分位数 1-3 范围]。使用引导程序实现组比较以定义 95% 置信限。

结果

59 名参与者提交了 6 次家庭考试，中位考试间隔为 8.0 [7.0-17] 天。每周测试（7 天±24 小时）的依从性为 55%。合规的主要障碍是 IT 后勤原因。在提交的 694 份家庭考试中，96% 是可靠的（FP<25%）。与 MaIA 相比，平板电脑返回的平均 RS 显着更高（+3.2 dB，p<0.05）。

结论

由于测试设计的不同，家庭监测产生了不同于临床测试的可靠结果。一旦建立了家庭基线，这不应影响自我监测，但这些差异将影响与临床结果的比较。达到了每周测试的合理合规性。改进的 IT 支持可能会带来更好的合规性。