Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- changes in the characteristics of the subbasal corneal plexus at confocal
研究概览
简要总结
This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled.
详细描述
This will be a single-centre, randomized, pilot study. 30 patients with diabetes who previously had received Argon laser photocoagulation will be enrolled. These patients will receive corneal esthesiometry and will be divided in those with esthesiometry < 45 mm [6] (clinically detectable corneal neuropathy, CDCN) and not (NCDCN).
Patients will be randomized to the two treatment arms: 20 patients will be treated with active treatment (OMK2) and 10 patients will be treated with placebo (lubricant eye drops) given three times daily (8 am, 2 pm, 8 pm) for 18 months. Stratification for (1) CDCN, (2) duration of the disease, and (3) insulin-dependent diabetes will be adopted.
The randomization will be operator-masked.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years old
- •Type 1 or type 2 diabetic patients who received Argon Laser Photocoagulation
排除标准
- •Neuropathy of any other cause than diabetes
- •A history of conditions known to affect corneal sensitivity
- •Coexisting other corneal diseases
- •Autoimmune diseases
- •Sjogren syndrome
- •History of corneal trauma
- •Contact lenses users
- •Patients needing eye surgery or who received eye surgery at least 180 days before study beginning.
- •contraindications to the use of any active substances and/or excipients
- •pregnant and lactating women
- •pediatric patients or adolescents under 18 years
研究组 & 干预措施
Active treatment
20 patients will be treated with active treatment (OMK2)
干预措施: OMK2 (Device)
Placebo
10 patients will be treated with placebo (lubricant eye drops)
干预措施: OMK2 (Device)
结局指标
主要结局
changes in the characteristics of the subbasal corneal plexus at confocal
时间窗: Change measure (baseline and month 18)
changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants) * changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and four quadrants changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants) * changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and changes in the characteristics of the subbasal corneal plexus at confocal microscopy (central + 8 paracentral quadrants) * changes in corneal esthesiometry (Cochet-Bonnet esthesiometer); central and four quadrants four quadrants
次要结局
- - changes in clinical signs and symptoms of ocular surface damage(Change measure (baseline and month 18))
研究者
Paolo Fogagnolo
Researcher
University of Milan