Retinal OCT Changes and Biomarkers in Drug-Resistant Epilepsy
Enrolling by invitation
Conditions studied: Epilepsy (Treatment Refractory), Epilepsy
In brief
This prospective, longitudinal observational study investigates whether epilepsy involves a progressive neurodegenerative process. Retinal structural and microvascular changes assessed by optical coherence tomography (OCT) and optical coherence (OCTA) will be analyzed alongside inflammatory biomarkers (sCD14, sCD163, CCL2, IL-1β). The study aims to explore their association with epilepsy pathophysiology, clinical phenotype, prognosis, and drug-resistant epilepsy (DRE). Among participants with epilepsy, seizure severity and antiseizure medication-related adverse-effect burden will also be assessed longitudinally using the National Hospital Seizure Severity Scale (NHS3) and the Turkish version of Liverpool Adverse Events Profile (LAEP-TR).
Key facts
- Study ID
- NCT07716930
- Run by
- Kemal Tutkavul
- People needed
- 250
- Starts
- 2026-07-01
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age between 18 and 40 years
- Ability to provide written informed consent
- For the epilepsy group: diagnosis of epilepsy for at least 1 year
- For the epilepsy group: treatment with at least one antiseizure medication for at least 1 year
- For the disease-control group: diagnosis of migraine, analgesic-overuse headache, or neuralgia
- For the disease-control group: current treatment with at least one antiseizure medication for a non-epileptic indication
- For the disease-control group: no history of epilepsy or unprovoked seizures
- For the healthy-control group: no history of epilepsy, major neurological disease, ophthalmological disease, or regular antiseizure medication use
You may not qualify if…
- Age younger than 18 years or older than 40 years
- Inability or unwillingness to provide written informed consent
- History of ocular surgery, ocular trauma, glaucoma, retinal disease, optic neuropathy, or severe refractive error, defined as spherical equivalent greater than ±6.0 diopters
- Media opacity or poor image quality preventing reliable OCT or OCTA assessment
- Vigabatrin or Valproate use
- Multiple sclerosis, Parkinson's disease, dementia, brain tumor, stroke, optic neuritis, or other major neurological disorders
- Evidence of visual pathway lesions on MRI
- Diabetes mellitus, uncontrolled hypertension, or other systemic vascular, metabolic diseases that may affect retinal or OCTA parameters
- Chronic alcohol or psychoactive substance abuse
- Inability to undergo OCT or OCTA examination because of cognitive, behavioral, or physical limitations
Where it is running
- Saglik Bilimleri University Haydarpasa Numune Education and Research Hospital Neurology Clinic — Istanbul, Turkey (Türkiye)
Full record on ClinicalTrials.gov
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