Association Between Autonomic Nervous System Dysfunction and Choroidal Vascularity Index (CVI) in Patients With Fibromyalgia: A Cross-Sectional Observational Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Choroidal Vascularity Index (CVI)
研究概览
简要总结
Fibromyalgia is frequently accompanied by autonomic nervous system dysfunction, often characterized by sympathetic predominance. Alterations in ocular microcirculation have been reported in the presence of autonomic dysfunction, including potential reductions in choroidal vascular parameters. This observational study aims to examine the association between autonomic symptom burden and the choroidal vascularity index (CVI), a quantitative marker of choroidal vascular structure derived from optical coherence tomography (OCT), in individuals with fibromyalgia compared with age- and sex-matched healthy controls.
详细描述
This is a cross-sectional, observational case-control study planned to investigate the relationship between autonomic nervous system dysfunction and choroidal vascularity index (CVI) in patients diagnosed with fibromyalgia according to the 2016 American College of Rheumatology (ACR) criteria. Participants will include adult females and males aged 18-50 years. Demographic and clinical data will be collected, including age, sex, body mass index (BMI), and disease duration.
Autonomic symptom burden will be assessed using the Composite Autonomic Symptom Score 31 (COMPASS-31). Fibromyalgia severity and its impact on daily functioning will be measured using the Revised Fibromyalgia Impact Questionnaire (FIQR). Central sensitization symptoms will be evaluated with the Central Sensitization Inventory (CSI).
All participants will undergo choroidal imaging using optical coherence tomography (OCT; Heidelberg Engineering, Heidelberg, Germany). CVI will be calculated as the ratio of luminal area to total choroidal area. To reduce operator-dependent variability, CVI quantification will be performed using an open-access artificial intelligence-assisted tool designed for choroidal layer analysis (ChoroidAI / choroidometer.com), with standardized image acquisition conditions.
Primary analyses will compare CVI between the fibromyalgia and control groups and evaluate associations between CVI and autonomic symptom burden, fibromyalgia impact, and central sensitization measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-50 years, female or male
- •Fibromyalgia group: diagnosis of fibromyalgia according to 2016 ACR criteria
- •Ability and willingness to provide written informed consent
- •Adequate ocular media clarity suitable for OCT imaging
- •Control group: age- and sex-matched healthy volunteers
排除标准
- •Ocular exclusions: cataract or other media opacity; glaucoma or optic nerve disease; ocular surface disorders (e.g., dry eye disease); retinal diseases (e.g., diabetic retinopathy, macular disease); ocular surgery or eye/head trauma within the last 3 months; best-corrected visual acuity < 20/20; refractive error > ±3.00 diopters; intraocular pressure > 21 mmHg; use of topical ophthalmic medications
- •Systemic/neurologic exclusions: diabetes mellitus; hypertension; hyperlipidemia; thyroid disorders; inflammatory rheumatic/autoimmune diseases; polyneuropathy or neurodegenerative disease; major depressive disorder or anxiety disorder; heavy smoking (>20 cigarettes/day); alcohol or substance dependence; excessive caffeine intake (>2.5 cups/day)
研究组 & 干预措施
Fibromiyalgia
Adults aged 18-50 years meeting the 2016 ACR criteria for fibromyalgia.
Healthy Controls
Age- and sex-matched healthy volunteers without fibromyalgia or major systemic/ocular disease.
结局指标
主要结局
Choroidal Vascularity Index (CVI)
时间窗: Single assessment at study visit (baseline)
CVI computed from OCT-derived choroidal images as luminal area / total choroidal area.
Autonomic Symptom Burden (COMPASS-31 total score)
时间窗: Single assessment at study visit (baseline)
次要结局
未报告次要终点
研究者
Dilara Ekici Zincirci
Medical Doctor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization