Cardiopulmonary Bypass, Diabetic Retinopathy (DR), Retinal Vascular Diseases
Conditions
Keywords
Diabetic Retinopathy, Cardiopulmonary Bypass, Pulsatile Flow
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Samsun University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 30 and 70 years 2. Undergoing elective, first-time coronary artery bypass graft surgery (CABG) 3. Stable metabolic status 4. For diabetic group: history of diabetes mellitus for more than 10 years 5. No significant ocular media opacity (e.g., cataract or vitreous hemorrhage) 6. No tremor or condition interfering with OCTA imaging 7. Aortic cross-clamp time ≤ 120 minutes
Exclusion criteria
1. Age \<30 or \>70 years 2. Re-do or emergency cardiac surgery 3. Diabetes duration \<10 years (for diabetic group) 4. Unstable metabolic state or active infection 5. Presence of significant cataract, vitreous hemorrhage, or tremor 6. Contraindications to OCTA imaging
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Choroidal Vascularity Index (CVI) from Baseline to 1-Month Postoperative | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Retinal Vascular Density (RVD) | 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. |
| Change in Foveal Avascular Zone (FAZ) Area | 1 month after surgery | FAZ area will be measured preoperatively and 1 month postoperatively using OCTA, and compared across study groups. |
| Comparison of CVI Change Between Diabetic and Non-Diabetic Patients | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed