Association Between Autonomic Dysfunction and Choroidal Vascularity Index in Fibromyalgia (NCT07345546) | Clinical Trial Compass
CompletedNot Applicable
Association Between Autonomic Dysfunction and Choroidal Vascularity Index in Fibromyalgia
Turkey (Türkiye)80 participantsStarted 2025-10-20
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Choroidal Vascularity Index (CVI)
Timeframe: Single assessment at study visit (baseline)
2
Autonomic Symptom Burden (COMPASS-31 total score)
Timeframe: Single assessment at study visit (baseline)
Trial details
NCT IDNCT07345546
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization