Prospective Study to Validate the Imaging Biomarker for Neuropathic Corneal Pain.
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 438
- 试验地点
- 3
- 主要终点
- Presence of microneuromas as assessed by in vivo confocal microscopy (IVCM).
研究概览
简要总结
The aim of this study is establish the reliability and clinical utility of microneuromas as identified via in vivo confocal microscopy as the diagnostic biomarker for NCP.
详细描述
Dry Eye Disease (DED) is a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities.
Neuropathic corneal pain (NCP), an ocular and severe type of neuropathic pain describes patients with symptoms of ocular discomfort out of proportion with clinical signs. The lack of clinical signs observed by standard ophthalmic examination has resulted in underdiagnosis of NCP or misdiagnosis as dry eye disease. Thus, having a biomarker for NCP is critical to identify and treat these patients. No biomarker or clinical signs exists to identify NCP patients.
Investigating corneal neurosensory abnormalities could help to diagnose NCP and potentially differentiate these patients from those with DED. In vivo confocal microscopy (IVCM) allows for real-time optical biopsies at a quasi-histological level, allowing for assessment of corneal nerves. IVCM non-invasive diagnostic imaging across NCP, DED, and healthy individuals will be analyzed to validate corneal microneuromas as a biomarker for NCP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Subjects:
- •18 years of age or older
- •Ability to consent
- •Best corrected visual acuity of 20/40 or better in each eye
- •Dry Eye Disease Group:
- •Chief complaint is ocular surface discomfort or dry eye disease, but subject reports no ocular pain on OPAS questionnaire
- •Symptoms lasting at least 3 months
- •Presence of at least two of the following within the same eye:
- •Anesthetized Schirmer score =/< 10mm
- •Corneal staining of >3/15 based on NEI scale
- •Tear break up time < 10 seconds
- •Neuropathic Corneal Pain Group:
- •Chief complain is ocular surface discomfort or dry eye disease
- •Symptoms lasting at least 3 months
- •All of the following in both eyes:
- •Corneal staining of less than or equal to 3/15 based on NEI scale
- •Tear break up time =/> 10 seconds
- •Must have at least 25% peripheral pain
- •Subject reported discomfort prior to drop response testing of at least 3 out of 10
- •Control Group:
- •No symptoms of ocular surface discomfort or dry eye disease
- •All of the following in both eyes
- •Anesthetized Schirmer score > 10 mm
- •Corneal staining of less than or equal to 3/15 based on NEI scale
- •Tear break up time > 10 seconds
- •The same sex and within 5 years of age of a patient within the NCP group.
排除标准
- •Pregnant or nursing
- •Irregular corneal disease
- •Ocular surgery in the past 3 months
- •Ocular infection in the past 3 months
- •Active ocular allergies
- •Participation in a study that could potentially impact the IVCM in the opinion of the investigator
- •Current use of corneal nerve regeneration therapy that has been on-going for 3 months or more.
- •For NCP group only, patients for whom their pain and symptoms can be attributed to other causes in the opinion of the investigator
结局指标
主要结局
Presence of microneuromas as assessed by in vivo confocal microscopy (IVCM).
时间窗: Day 1
The obtained sequence of IVCM imaging scans of both eyes will be evaluated for findings of microneuromas; defined as either observed presence or absence of microneuroma
次要结局
- Ocular Pain Assessment Survey (OPAS) questionnaire results correlation to microneuromas; OPAS reported quality of life score compared across the 3 cohorts.(Day 1)
- Establish the reference interval for the microneuroma biomarker(Day 1)
- Hyperosmolar functional nerve tests in correlation to microneuromas; hyperosmolar functional nerve tests results compared cross cohorts(Day 1)
- Intra-subject repeatability; Presence of the microneuroma biomarker in the same participant at 2 weeks(From Day 1 to 2 weeks)
- Test the utility of already configured AI software to diagnose NCP patients(Day 1 to 2 weeks)