Choroidal Changes During Cardiopulmonary Bypass

NCT07034612 | Completed

• 1 other identifier: SamsunKVC OCT
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Retinopathy (DR); Cardiopulmonary Bypass; Retinal Vascular Diseases

Keywords

Diabetic Retinopathy; Cardiopulmonary Bypass; Pulsatile Flow

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 month after surgery

Secondary Outcomes (3)

• Change in Retinal Vascular Density (RVD)

  1 month after surgery

• Change in Foveal Avascular Zone (FAZ) Area

  1 month after surgery

• Comparison of CVI Change Between Diabetic and Non-Diabetic Patients

  1 month after surgery

Study Arms (4)

Diabetic - Pulsatile Flow

Diabetic patients undergoing elective coronary artery bypass grafting (CABG) with pulsatile cardiopulmonary bypass (CPB) flow. Preoperative and postoperative 1st month OCTA measurements will be taken.

Diabetic - Non-Pulsatile Flow

Diabetic patients undergoing elective CABG with non-pulsatile CPB flow. OCTA measurements preoperatively and at 1 month postoperatively.

Non-Diabetic - Pulsatile Flow

Non-diabetic patients undergoing elective CABG with pulsatile CPB flow. OCTA measurements preoperatively and at 1 month postoperatively.

Non-Diabetic - Non-Pulsatile Flow

Non-diabetic patients undergoing elective CABG with non-pulsatile CPB flow. OCTA measurements preoperatively and at 1 month postoperatively.

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients scheduled for elective coronary artery bypass grafting, including diabetic and non-diabetic individuals, recruited at a single center (Samsun Training and Research Hospital).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun University: lead

Study Sites (1)

Samsun University Faculty of Medicine

Samsun, 55090, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2025
• First Posted: June 24, 2025
• Study Start: January 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

TU (1)