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Association Between Autonomic Dysfunction and Choroidal Vascularity Index in Fibromyalgia

Key facts

Who runs it
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Where
Türkiye1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
80 people enrolled
Started
20 Oct 2025
Ended
19 Dec 2025
Type of study
Observational, 2 groups
Record updated
8 April 2026

Who can take part

Age
18 years to 50 years
Sex
Women and men
Healthy volunteers
Can take part

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • 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.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Association Between Autonomic Nervous System Dysfunction and Choroidal Vascularity Index (CVI) in Patients With Fibromyalgia: A Cross-Sectional Observational Case-Control Study
Record updated
8 April 2026