CompletedNot Applicable

Choroidal Changes During Cardiopulmonary Bypass

Turkey (Türkiye)102 participantsStarted 2023-01-01

Plain-language 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.

Who can participate

Age range

30 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 1 month after surgery

Trial details

NCT IDNCT07034612

SponsorSamsun University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-01-01

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