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Association Between Autonomic Dysfunction and Choroidal Vascularity Index in Fibromyalgia

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07345546
Enrollment
80
Registered
2026-01-15
Start date
2025-10-20
Completion date
2025-12-19
Last updated
2026-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autonomic Dysfunction, Fibromyalgia

Keywords

fibromiyalgia

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Choroidal Vascularity Index (CVI)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)Single assessment at study visit (baseline)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 9, 2026