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NCT Number: NCT07345546

Association Between Autonomic Dysfunction and Choroidal Vascularity Index in Fibromyalgia

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. Choroidal Vascularity Index (CVI)

    Time frame: Single assessment at study visit (baseline)

    CVI computed from OCT-derived choroidal images as luminal area / total choroidal area.

  2. Autonomic Symptom Burden (COMPASS-31 total score)

    Time frame: Single assessment at study visit (baseline)

Sponsors and collaborators

Lead sponsor

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization

Other

Registry information

Official study title

Association Between Autonomic Nervous System Dysfunction and Choroidal Vascularity Index (CVI) in Patients With Fibromyalgia: A Cross-Sectional Observational Case-Control Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 15, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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