Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
102 participants
OBSERVATIONAL
2023-01-01
2025-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Diabetic - Non-Pulsatile Flow
Diabetic patients undergoing elective CABG with non-pulsatile CPB flow. OCTA measurements preoperatively and at 1 month postoperatively.
No interventions assigned to this group
Non-Diabetic - Pulsatile Flow
Non-diabetic patients undergoing elective CABG with pulsatile CPB flow. OCTA measurements preoperatively and at 1 month postoperatively.
No interventions assigned to this group
Non-Diabetic - Non-Pulsatile Flow
Non-diabetic patients undergoing elective CABG with non-pulsatile CPB flow. OCTA measurements preoperatively and at 1 month postoperatively.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
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
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
30 Years
70 Years
ALL
No
Sponsors
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Samsun University
OTHER
Responsible Party
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Locations
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Samsun University Faculty of Medicine
Samsun, , Turkey (Türkiye)
Countries
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Other Identifiers
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SamsunKVC OCT
Identifier Type: -
Identifier Source: org_study_id
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