【ChiCTR2000034006】A randomised controlled trial for investigation of the safety and efficacy of treating diabetic macular edema using Noctura 400 sleep mask

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基本信息

登记号

ChiCTR2000034006

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2020-06-21

临床申请受理号

靶点

适应症

diabetic retinopathy, diabetic macular oedema

试验通俗题目

A randomised controlled trial for investigation of the safety and efficacy of treating diabetic macular edema using Noctura 400 sleep mask

试验专业题目

A randomised controlled study investigating the safety and efficacy of treating diabetic macular edema using Noctura 400 sleep mask

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临床试验信息

试验目的

The aim of the evaluation is to compare and observe the efficacy of two different light emitted levels of Noctura 400 sleep mask on 300 patients with early DMO over a period of 12 months. 150 patients will be assigned randomly to each group. One group will receive the standard treatment of 2 scotopic trolands and the other will receive the lower level of light being tested which is 0.03 scotopic trolands. The results of the two groups will be compared. Results will be compared the efficacy of treatment in the two arms and their significance in the treatment of diabetic macular edema and to corelate with the level of compliance in each arm. Proposing that a low level of light will provide similar efficacy with better compliance In this study the analysis will focus on the change in key measures of diabetic macular oedema and the classification level of diabetic retinopathy. Observations will also include the need to administer standard treatments in parallel with mask use. An interim analysis will be carried out at 6 months, to ensure the study is powered correctly and to allow early publication of data if a strong efficacy signal is significant.

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试验类型

随机平行对照

试验分期

其它

随机化

This will be a prospective, double-masked, randomized controlled study. Patients will be randomized into Noctura 400 sleep mask 0.03 scotopic trolands group or the standard 2 scotopic trolands group at a ratio of 1:1. The randomization sequence will be generated using a computerized randomization table kept central

盲法

The randomization sequence will be generated using a computerized randomization table kept centrally by a research assistant. All patients and investigators will be masked to the treatment allocation group. Assessors performing the follow-up assessments also will be masked to the patient allocation group.

试验项目经费来源

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong; Health and Medical Research Fund 2019 (pending)

试验范围

目标入组人数

150

实际入组人数

第一例入组时间

2020-11-01

试验终止时间

2023-10-31

是否属于一致性

入选标准

1. Adults (over 18 years old); 2. DM type 1 or 2; 3. Presence of diabetic macular oedema (DMO); 4. Patients who can give an HbA1c level throughout the study; 5. No previous treatments within 6months of baseline visit; 6. Any stage of non-proliferative diabetic retinopathy.；

排除标准

1. Pregnant; 2. Advanced cataract or other media opacity which precludes a fundal view; 3. Any proliferative diabetic retinopathy including advanced diabetic eye disease (vitreous haemorrhage or tractional retinal detachment); 4. Unstable or poorly controlled diabetes (HbA1c levels >15); 5. Contraindications listed in the instruction of Noctura 400; 6. Unable to complete giving consent form.；

研究者信息

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试验机构

Research Fund Secretariat, Food and Health Bureau, The Government of HKSAR

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