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OpenTrials
Completed

NCT Number: NCT06442176

Choroid In Coronary Artery Disease

Purpose: To investigate any relationship between choroid thickness (CTh) and coronary artery disease (CAD), particularly in its earlier stages before clinically evident.

Design: Retrospective, cross-sectional observational study

Methods:

Setting: The study was performed in two institutions; patients were recruited in Balikesir City Hospital. The ophthalmological examinations and coronary angiograms were performed in Balikesir City Hospital. The analysis of the coronary angiograms including Gensini scoring were conducted in Bursa Education and Research Hospital.

Study Population: The study group comprised 68 patients with documented CAD and 60 healthy control subjects. Patients with high myopia, cataracts, retinal vascular disease, retinal surgery, retinal dystrophy, laser photocoagulation, intravitreal anti-VEGF treatment, glaucoma, uveitis, retinal disorders, any systemic diseases were excluded from the study groups.

Observation Procedure: Refractive examination, corrected visual acuity, intraocular pressure measurements, anterior and posterior segment examinations. Following measurements of macular thickness and retinal nerve fiber layer, choroidal thickness of both eyes was assessed by enhanced depth imaging optical coherence tomography.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Balikesir City Hospital

Balıkesir, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normal coronaries at coronary angiography for healthy control group
  • Without any coronary artery disease equivalent diseases such as peripheral artery disease, cerebrovascular disease and stroke for healthy control group
  • Ability to give informed consent for the study
  • Coronary artery disease with stenosis detected in coronary angiogram for coronary artery disease group

Exclusion criteria

  • High myopia (> 6D)
  • Cataracts
  • Retinal vascular disease
  • Retinal surgery
  • Retinal dystrophy
  • Laser photocoagulation
  • Intravitreal anti-VEGF treatment
  • Glaucoma
  • Uveitis
  • Retinal disorders (comprising diabetic macular edema, diabetic/hypertensive retinopathy, vein occlusions, retinal dystrophy, epiretinal membrane, vitreomacular traction, age-related macular degeneration)
  • Any systemic diseases
  • Obesity (body-mass index ≥30 kg/m²)

Treatment and study plan

OCT

Diagnostic Test

Enhanced depth imaging optical coherence tomography (EDI-OCT) using the Heidelberg Spectralis HRA + OCT (Heidelberg Engineering, Inc., Franklin, MA, USA)

Primary outcomes

  1. Choroidal thickness in Healthy Subjects

    Time frame: 1 day

    micron

  2. Choroidal thickness in patients with coronary artery disease

    Time frame: 1 day

    micron

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Choroid Thickness May Shed Light On Early Coronary Artery Disease

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jun 4, 2024
Registry last updated
Jun 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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