Assessing the Efficacy of Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change to Overall Pain by the Visual Analogue Scale (VAS) After Intranasal Neurostimulator (ITN) Stimulation at Baseline
研究概览
简要总结
This study is a prospective, interventional, open-label, single arm, non-randomized trial treating 30 patients with peripheral or mixed neuropathic corneal pain at their baseline exam and following 45 days and 90 days of daily use with the TrueTear™ ITN device.
详细描述
The investigators hypothesize that the stimulation through the ethmoidal nerve in the nasal cavity may have an inhibitory effect on the primary TG interneurons and block the ocular pain signaling to the brain.
The investigators propose a non-randomized, open-label, single arm pilot trial for treatment of neuropathic corneal pain (NCP) with ITN with the following specific aims:
Specific Aims:
- To elucidate the efficacy of ITN in ameliorating pain among neuropathic corneal pain patients.
- To elucidate the safety, efficacy, longevity of ITN in ameliorating pain among neuropathic corneal pain patients during a 90-day period with daily use.
- To assess quality of life changes by treating neuropathic corneal pain with ITN during a 90-day period with daily use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to consent to study.
- •Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.
- •Positive in vivo confocal microscopy (IVCM) findings for NCP such as presence of microneuromas and decreased nerve density.
- •Fifty percent or more relief of pain or discomfort after instillation of Proparacaine eye drops as measured by the Visual Analogue Scale (VAS).
排除标准
- •Clinically significant acute ocular surface diseases, such as active infectious keratitis or recent ocular surgery in the past 3 months.
- •Chronic or recurrent epistaxis, coagulation disorders.
- •Nasal or sinus surgery or significant trauma to the nose.
- •Severe nasal airway obstruction or vascularized nasal polyps.
- •Cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck.
- •Chronic or recurrent nosebleeds
- •Bleeding disorder
- •Known hypersensitivity (allergy) to the hydrogel material
- •Disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device.
结局指标
主要结局
Change to Overall Pain by the Visual Analogue Scale (VAS) After Intranasal Neurostimulator (ITN) Stimulation at Baseline
时间窗: immediately before and after ITN on Day 1 (baseline)
The Visual Analogue Scale (VAS) is a 10 cm line, with one end labeled 'no pain' (which is equivalent to a score of 0 on the numerical scale) and the other end labeled 'worst pain imaginable' (which is equivalent to a score of 10 on the numerical scale). The patient is asked to mark the scale according to the intensity of their eye pain, and the examiner measures the distance in centimeters from the 'no pain' end of the line to score the VAS. The level of discomfort/pain before and after ITN was assessed using the VAS questionnaire (0-10). The changes in overall eye pain after ITN were recorded. Higher scores on the VAS indicate more intense pain and a worse outcome.
次要结局
- Change to Overall Pain by the Visual Analogue Scale (VAS) After Daily Intranasal Neurostimulator (ITN) Stimulation Over 45-day Period(immediately before and after ITN on Day 45)
- Change to Overall Pain by the Visual Analogue Scale (VAS) After Daily Intranasal Neurostimulator (ITN) Stimulation Over 90-day Period(immediately before and after ITN on Day 90)
- Quality of Life as Measured With OPAS at Baseline(Day 1 (Baseline))
- Overall Percent Change on Impact of Dry Eye in Everyday Life (IDEEL)(Baseline vs day 45 visit and Baseline vs day 90 visit)
- Change in the Intraocular Pressure (IOP) Measured in Each Visit.(Baseline vs day 45 visit and Baseline vs day 90 visit)
- Number of Participants With Adverse Events (Safety)(90 days)
- Reduction on Other Concomitant Pain Therapy(Baseline vs 45 Day Visit and baseline vs 90 Day Visit)
- Quality of Life as Measured Daily With OPAS at 45 Days(45 days)
- Quality of Life as Measured Daily With OPAS at 90 Days(90 days)
- Overall Change in Quality of Life as Measured Daily With OPAS(Baseline vs day 45 visit and Baseline vs day 90 visit)
- Percent Change From Pain Level Dimension Questions of the Ocular Pain Assessment Survey (OPAS)(Baseline vs day 45 visit and Baseline vs day 90 visit)
- Number of Participants With Adverse Events (Tolerability)(90 days)