A randomised controlled study investigating the safety and efficacy of treating diabetic macular edema using Noctura 400 sleep mask
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 4
- 主要终点
- Best corrected visual acuity (BCVA)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 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.
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- Male
入选标准
- •Adults (over 18 years old);
- •DM type 1 or 2;
- •Presence of diabetic macular oedema (DMO);
- •Patients who can give an HbA1c level throughout the study;
- •No previous treatments within 6months of baseline visit;
- •Any stage of non-proliferative diabetic retinopathy.
排除标准
- •Advanced cataract or other media opacity which precludes a fundal view;
- •Any proliferative diabetic retinopathy including advanced diabetic eye disease (vitreous haemorrhage or tractional retinal detachment);
- •Unstable or poorly controlled diabetes (HbA1c levels >15);
- •Contraindications listed in the instruction of Noctura 400;
- •Unable to complete giving consent form.
研究组 & 干预措施
Group 1
Noctura 400 (0.03 scotopic troland) sleep mask
Group 2
Noctura 400 (2 scotopic trolands) sleep mask
结局指标
主要结局
Best corrected visual acuity (BCVA)
时间窗: 12 months
Macular thickness in each zone of the ETDRS Grid
时间窗: 12 months
Maximum retinal thickness, average central subfield thickness (CST), central maximum thickness (Cmax)
时间窗: 12 months
Other anatomical changes
时间窗: 12 months
Diabetic retinopathy severity level
时间窗: 12 months
Number of standard treatments required (Anti-VEGF injections, laser, etc.)
时间窗: 12 months
Microperimetry
时间窗: 12 months
次要结局
- Safety of using the Noctura 400(12 months)