Skip to main content
OpenTrials
Completed

NCT Number: NCT07034612

Choroidal Changes During Cardiopulmonary Bypass

This prospective observational study investigates the impact of pulsatile versus non-pulsatile cardiopulmonary bypass (CPB) flow on choroidal circulation in diabetic and non-diabetic patients undergoing elective coronary artery bypass grafting (CABG). A total of 104 patients aged 30 to 70 years will be included, with balanced distribution between diabetic and non-diabetic groups. Optical coherence tomography angiography (OCTA) will be performed preoperatively and at 1 month postoperatively to assess changes in choroidal vascularity. The primary objective is to determine whether the type of CPB flow affects choroidal microcirculation, particularly in diabetic patients. The findings may support more individualized perfusion strategies in patients at risk of ocular microvascular impairment.

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsun University Faculty of Medicine

Samsun, 55090, Turkey (Türkiye)

About this study

This prospective observational study aims to investigate the effects of pulsatile and non-pulsatile cardiopulmonary bypass (CPB) flow types on choroidal and retinal microcirculation in diabetic and non-diabetic patients undergoing elective coronary artery bypass graft (CABG) surgery. Previous literature suggests that pulsatile perfusion may enhance end-organ perfusion, but data on ocular microvascular circulation remain scarce, especially in diabetic patients.

A total of 104 patients between the ages of 30 and 70 will be enrolled and divided into four groups based on diabetes status and CPB flow type. Optical coherence tomography angiography (OCTA) will be performed preoperatively and at 1 month postoperatively to measure the choroidal vascularity index (CVI) and other retinal microvascular parameters.The primary outcome is the change in CVI between baseline and 1-month follow-up. Secondary outcomes include retinal microvascular changes and comparative analyses between diabetic and non-diabetic groups.By evaluating the relationship between CPB flow type and ocular perfusion, particularly in patients with longstanding diabetes, this study may provide evidence to support individualized CPB strategies to minimize ocular microvascular compromise in cardiac surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age between 30 and 70 years
  • Undergoing elective, first-time coronary artery bypass graft surgery (CABG)
  • Stable metabolic status
  • For diabetic group: history of diabetes mellitus for more than 10 years
  • No significant ocular media opacity (e.g., cataract or vitreous hemorrhage)
  • No tremor or condition interfering with OCTA imaging
  • Aortic cross-clamp time ≤ 120 minutes

Exclusion criteria

  • Age <30 or >70 years
  • Re-do or emergency cardiac surgery
  • Diabetes duration <10 years (for diabetic group)
  • Unstable metabolic state or active infection
  • Presence of significant cataract, vitreous hemorrhage, or tremor
  • Contraindications to OCTA imaging

Treatment and study plan

Primary outcomes

  1. Change in Choroidal Vascularity Index (CVI) from Baseline to 1-Month Postoperative

    Time frame: 1 month after surgery

    CVI will be calculated from OCTA images preoperatively and 1 month postoperatively. Mean change in CVI will be compared between pulsatile and non-pulsatile CPB groups.

Secondary outcomes

  1. Change in Retinal Vascular Density (RVD)

    Time frame: 1 month after surgery

    RVD will be assessed by OCTA and measured as vessel density (%) at baseline and 1-month post-op, compared between study groups.

  2. Change in Foveal Avascular Zone (FAZ) Area

    Time frame: 1 month after surgery

    FAZ area will be measured preoperatively and 1 month postoperatively using OCTA, and compared across study groups.

  3. Comparison of CVI Change Between Diabetic and Non-Diabetic Patients

    Time frame: 1 month after surgery

    Subgroup analysis of CVI change will be performed to assess whether diabetes status affects choroidal perfusion response to CPB flow type.

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

Effect of Pulsatile and Non-Pulsatile Cardiopulmonary Bypass Flow on Choroidal Circulation in Diabetic and Non-Diabetic Patients

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Jun 27, 2025

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.

Published trials that share one or more normalized conditions with this study.