Fielder A R, Irwin M, Auld R, Cocker K D, Jones H S, Moseley M J
Academic Unit of Ophthalmology, University of Birmingham Medical School.
Br J Ophthalmol. 1995 Jun;79(6):585-9. doi: 10.1136/bjo.79.6.585.
AIM/BACKGROUND: This study aimed to determine the feasibility of objective compliance monitoring of amblyopia therapy in clinical research. Occlusion has been the mainstay of amblyopia therapy for over 250 years, yet it has never been subjected to rigorous evaluation. Treatment regimens range arbitrarily from a few minutes to most of the waking hours of the day. Compliance is problematic and as, hitherto, accurate objective monitoring has been impossible it is not known how much occlusion is required to effect an improvement in vision.
An occlusion dose monitor (ODM) has been developed. The ODM consists of a modified occlusion patch and a miniature battery driven datalogger which periodically monitors patch skin contact. The patch is a standard disposable item with two miniature electrocardiogram electrodes attached to its undersurface. The datalogger comprises a high speed static RAM and a clock driven address counter. Data are retrieved using an IBM PC/AT computer. Fifteen child amblyopes were randomly allocated unilateral occlusion of 1, 4, or 8 hours per day for 4 weeks. Owing to data loss, presumed because of accumulation and discharge of static electricity, an additional child was included in the 8 hour group. Outcome measures were objective (ODM) and subjective (diary) compliance with treatment, logMAR visual acuity, and contrast sensitivity.
Objective monitoring of occlusion is technically feasible and clinically informative.
Objective monitoring of occlusion has opened up new research opportunities which, it is hoped, will enable the dose-effect relation of occlusion therapy in the various types of amblyopia to be investigated objectively, and facilitate the design of effective therapeutic regimens.
目的/背景：本研究旨在确定在临床研究中对弱视治疗进行客观依从性监测的可行性。在超过250年的时间里，遮盖疗法一直是弱视治疗的主要方法，但从未接受过严格评估。治疗方案从几分钟到一天中大部分清醒时间不等，具有很大随意性。依从性存在问题，而且由于迄今为止无法进行准确的客观监测，尚不清楚需要多少遮盖时间才能使视力得到改善。
已开发出一种遮盖剂量监测仪（ODM）。该监测仪由一个改良的遮盖眼罩和一个由微型电池驱动的数据记录器组成，数据记录器可定期监测眼罩与皮肤的接触情况。眼罩是一种标准的一次性用品，其底面附有两个微型心电图电极。数据记录器包括一个高速静态随机存取存储器和一个由时钟驱动的地址计数器。使用IBM个人计算机/AT计算机检索数据。15名弱视儿童被随机分配为每天接受1、4或8小时的单侧遮盖，为期4周。由于数据丢失（推测是由于静电的积累和释放），8小时组额外纳入了一名儿童。观察指标包括治疗的客观（ODM）和主观（日记）依从性、对数最小分辨角视力和对比敏感度。
对遮盖进行客观监测在技术上是可行的，且具有临床指导意义。
对遮盖的客观监测开辟了新的研究机会，有望使人们能够客观地研究各种类型弱视中遮盖治疗的剂量-效应关系，并有助于设计有效的治疗方案。
