Neuroplasticity of Pain Pathways and Corneal Afferent Regeneration Following Corneal Crosslinking (CXL) in Keratoconus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Neural activity related to pain.
研究概览
简要总结
Evaluation of neuroplasticity of pain pathways and corneal afferent nerve regeneration following corneal crosslinking (CXL) in keratoconus patients using fMRI and corneal In Vivo Confocal Microscopy (IVCM).
详细描述
Our long-term goal is to evaluate the transition from acute to chronic pain that sometimes occurs following CXL in keratoconus patients. This study will determine whether these changes can be structurally and functionally quantified using functional neuroimaging and in vivo corneal microscopy (IVCM), and whether they can be predicted based on predisposing biological and psychological factors. Our central hypothesis is that CXL produces acute pain through activation of trigeminal afferents, and that post-operative chronic pain outcomes are related to neuroplastic changes in trigeminal circuitry, corneal afferent regeneration, and psychological factors.
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
- 8 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 8-35 years
- •Clinical diagnosis of keratoconus and seeking CXL treatment
- •English speaking ability sufficient to comprehend consent with parental assistance
- •MRI compatible
- •Ability to lie still for an MRI session (60 minutes)
- •Control Group
- •Age 8-35 years
- •No diagnosis of keratoconus
- •English speaking ability sufficient to comprehend consent with parental assistance
- •MRI compatible
- •Ability to lie still for an MRI session (60 minutes)
- •Exclusion Criteria (Both Groups):
- •Claustrophobic
- •Weight > 285 lbs (weight limit of the MRI table)
- •Significant medical history, including:
- •Current DSM-IV-TR axis I psychiatric disorders. Chronic pain Significant head injury Seizures Brain tumor Cerebrovascular accident Neurological disease aside from migraine HIV-AIDs Prescription medication strongly implicated in causing dry eyes
- •Magnetic implants or metal-containing tattoos on their chest or above
- •Pregnancy
- •History of contact lens wear
- •Any allergic response to a numbing eyedrop in the past
排除标准
- 未提供
结局指标
主要结局
Neural activity related to pain.
时间窗: 1 year
Pain-related brain activation measured with fMRI.
Corneal nerve morphology.
时间窗: 1 year
Afferent nerve fiber morphology measured with IVCM.
次要结局
未报告次要终点
研究者
Eric Moulton
Assistant Professor of Anesthesia
Boston Children's Hospital