Association Between Autonomic Dysfunction and Choroidal Vascularity Index in Fibromyalgia

NCT07345546 | Completed

• 1 other identifier: Fibromiyalgia2
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Autonomic Dysfunction

Keywords

fibromiyalgia

Outcome Measures

Primary Outcomes (2)

• Choroidal Vascularity Index (CVI)

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

  Single assessment at study visit (baseline)

• Autonomic Symptom Burden (COMPASS-31 total score)

  Single assessment at study visit (baseline)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Adults aged 18-50 years with fibromyalgia and matched healthy controls recruited from Prof. Dr. Cemil Taşcıoğlu City Hospital in Istanbul, Turkey.

You may qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

Prof. Dr. Cemil Taşçıoğlu Şehir Hastanesi

Istanbul, Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Primary Dysautonomias

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Autonomic Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 25, 2025
• First Posted: January 15, 2026
• Study Start: October 20, 2025
• Primary Completion: December 18, 2025
• Study Completion: December 19, 2025
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

TU (1)