NCT05523531已完成不适用
Description of Symptoms, Impact on Quality of Life, Ophthalmological Examination and Treatment of Patients With Neuropathic Eye Pain Associated With Dry Eye: a Prospective Single-center Long-term Follow-up Study of a Series of Cases Previously Included in the QUALVIDON Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Assessment of neuropathic eye pain
研究概览
简要总结
Dry eye affects millions of people around the world. Some dry eye patients complain of neuropathic eye pain that can affect their quality of life.
From August 2016 to June 2017, the QUALVIDON study (NCT03296111), conducted at the Adolphe de Rothschild Foundation Hospital, assessed pain and its impact on quality of life using self-administered questionnaires in a series of dry eye patients. This 2nd study, entitled QUALVIDON2, focuses on the outcome of patients previously included in QUALVIDON.
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
- •Patients previously included in the QUALVIDON study with the following characteristics:
- •With characteristics of idiopathic neuropathic eye pain associated with dry eye
- •Give informed consent
- •Affiliated or beneficiary of the french social security
排除标准
- •Pregnant or nursing woman
- •Patient under legal protection
结局指标
主要结局
Assessment of neuropathic eye pain
时间窗: at 5 years follow-up
Total score of the french neuropathic eye pain questionnaire (QDON) Range from 0 to 28. A score with higher value reflects a more severe disease.
次要结局
- Assessment of Oxford score(at 5 years follow-up)
- Diagnosis of blepharitis(at 5 years follow-up)
- Assessment of corneal sensitivity(at 5 years follow-up)
- Assessment of Schirmer's test(at 5 years follow-up)
- Assessment of Meibomian gland dysfunction(at 5 years follow-up)
- Assessment of dry eye severity(at 5 years follow-up)
- Assessment of Tear break up time(at 5 years follow-up)
- Assessment of the thickness of tear film lipid Layer(at 5 years follow-up)
- Diagnosis of atrophy of the Meibomian glands(at 5 years follow-up)
- Visual impact of dry eye(at 5 years follow-up)
- Psychologic impact of eye pain(at 5 years follow-up)
- Drug effectivness (pain relief)(at 5 years follow-up)
- General impact of eye pain(at 5 years follow-up)
- Drug safety(at 5 years follow-up)
研究者
研究点 (1)
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