An Investigator-Initiated Study to Assess the Association of Diabetic Retinopathy Severity Scale (DRSS) With Level of Decreased Corneal Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Primary Endpoint
研究概览
简要总结
Evaluate the association between level of decreased corneal sensitivity and diabetic retinopathy severity scale
详细描述
This study is assessing the association between neurotrophic keratopathy and diabetic retinopathy severity by examining subjects with diabetic retinopathy to associate DRSS and disease characteristics with corneal desensitization. In addition, to better understand the relationship of disease duration, HbA1c, and status of concurrent systemic therapies and diabetic retinopathy treatments, predictive modelling will be performed to determine predictive factors of patients at highest risk of developing reduced corneal sensitivity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have Type 1 or Type 2 diabetes with DRSS of 3 or higher
- •Be willing and able to sign the informed consent form (ICF)
- •Be at least 18 years of age
- •Be literate and able to complete questionnaires independently
- •Have provided verbal and written informed consent
排除标准
- •Have a history of vitrectomy
- •Have a history of cornea, eyelid, glaucoma, or retina surgery
- •Have a history of previously diagnosed neurotrophic keratopathy or other cranial nerve V pathology, such as trigeminal neuralgia
- •Have a history of ocular herpes simplex virus infection
- •Have a history of herpes zoster ophthalmicus
- •Have a history of ocular chemical trauma
- •Have a history of underlying corneal dystrophies
- •Have had cataract surgery less than 3 months prior
- •Have a history of pan-retinal photocoagulation (PRP)
- •Have current Stage 2 or 3 neurotrophic keratopathy
- •Have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
- •Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days prior to Visit 1
结局指标
主要结局
Primary Endpoint
时间窗: 3months
• To associate the Diabetic Retinopathy Severity Scale level 3 or higher (as confirmed by masked reading center) with the level of decreased corneal sensitivity in patients with Type 1 and Type 2 diabetes
次要结局
未报告次要终点