Neurosensory Abnormalities in SymptomAtic Ocular Surface Patients (NASA)
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 1,000
- 试验地点
- 30
- 主要终点
- To establish the prevalence of neuropathic corneal pain in patients with ocular surface discomfort.
研究概览
简要总结
This study is designed to measure how common nerve abnormalities are within a group of patients who feel discomfort within their eyes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- 否
入选标准
- •Presents with ocular surface discomfort or for dry eye care
- •Best corrected visual acuity of 20/40 or better in each eye
- •Subject reported duration of symptoms of at least 3 months
- •100 subjects will be required to be habitual contact lens wearers as defined by use of contact lenses at least 5 hours per day at least 5 days per week for the last year.
排除标准
- •Use of contact lenses on the day of the visit
- •Pregnant or nursing
- •Irregular corneas (e.g., ectatic disease, transplantation, or corneal dystrophies)
- •Ocular surgery in the past 3 months
- •Ocular infection in the past 3 months
- •Active ocular allergies
研究组 & 干预措施
Neuropathic Corneal Pain with Dry Eye Disease
Participants diagnosed with dry eye disease and neuropathic corneal pain
干预措施: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers (Other)
Neuropathic Corneal Pain with Ocular Surface Discomfort
Participants diagnosed with neuropathic corneal pain with ocular surface discomfort
干预措施: Hyperosmolar Response (Other)
Neuropathic Corneal Pain with Ocular Surface Discomfort
Participants diagnosed with neuropathic corneal pain with ocular surface discomfort
干预措施: Proparacaine Challenge Test (Other)
Neuropathic Corneal Pain with Ocular Surface Discomfort
Participants diagnosed with neuropathic corneal pain with ocular surface discomfort
干预措施: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers (Other)
Neuropathic Corneal Pain with Ocular Surface Discomfort
Participants diagnosed with neuropathic corneal pain with ocular surface discomfort
干预措施: Ocular Pain Assessment Survey (OPAS) (Other)
Neuropathic Corneal Pain with Ocular Surface Discomfort
Participants diagnosed with neuropathic corneal pain with ocular surface discomfort
干预措施: Visual Analogue Questionnaire (Other)
Neuropathic Corneal Pain with Dry Eye Disease
Participants diagnosed with dry eye disease and neuropathic corneal pain
干预措施: Hyperosmolar Response (Other)
Neuropathic Corneal Pain with Dry Eye Disease
Participants diagnosed with dry eye disease and neuropathic corneal pain
干预措施: Proparacaine Challenge Test (Other)
Neuropathic Corneal Pain with Dry Eye Disease
Participants diagnosed with dry eye disease and neuropathic corneal pain
干预措施: Ocular Pain Assessment Survey (OPAS) (Other)
Neuropathic Corneal Pain with Dry Eye Disease
Participants diagnosed with dry eye disease and neuropathic corneal pain
干预措施: Visual Analogue Questionnaire (Other)
NCP or Dry Eye in patients with ocular surface discomfort
Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort
干预措施: Hyperosmolar Response (Other)
NCP or Dry Eye in patients with ocular surface discomfort
Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort
干预措施: Proparacaine Challenge Test (Other)
NCP or Dry Eye in patients with ocular surface discomfort
Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort
干预措施: Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers (Other)
NCP or Dry Eye in patients with ocular surface discomfort
Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort
干预措施: Ocular Pain Assessment Survey (OPAS) (Other)
NCP or Dry Eye in patients with ocular surface discomfort
Participants diagnosed with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort
干预措施: Visual Analogue Questionnaire (Other)
结局指标
主要结局
To establish the prevalence of neuropathic corneal pain in patients with ocular surface discomfort.
时间窗: Day 1
As measured by the percent of subjects who report increased ocular surface discomfort upon challenge with hyperosmolar saline.
To establish the prevalence of subtypes of patients with neuropathic corneal pain or with a neuropathic component of dry eye in patients with ocular surface discomfort.
时间窗: Day 1
As measured by the percent of subjects who report ocular surface discomfort, and have a decrease, partial decrease, or no change in Visual Analog Score score upon instillation of proparacaine.
To assess the overlap of neuropathic corneal pain with dry eye disease in patients in diseases that are currently thought to be mutually exclusive.
时间窗: Day 1
As measured by the percent of subjects who report ocular surface discomfort, and either do or do not exhibit signs of dry eye disease as defined by Tear Break Up Time, Schirmer's test, and staining, and have an increase in Visual Analog Scale score of more than 2 steps upon instillation of hypertonic saline.
次要结局
- To establish the prevalence of anxiety/depression in patients with neuropathic corneal pain patients.(Day 1)
- To assess the overlap of neuropathic corneal pain and contact lens discomfort.(1 study visit)
- To assess for differences in in vivo confocal microscopy measures between dry eye disease patients and neuropathic corneal pain patients.(Day 1)
- To assess for subtypes of neuropathic corneal pain differences in in vivo confocal microscopy measures between dry eye disease patients and neuropathic corneal pain patients.(Day 1)