Diabetic Retinopathy (DR)NCT07034612
Choroidal Changes During Cardiopulmonary Bypass
An observational study of Diabetic Retinopathy (DR) and Cardiopulmonary Bypass, run by Samsun University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Retinopathy (DR), Cardiopulmonary Bypass, Retinal Vascular Diseases
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University Faculty of Medicine
Samsun, 55090
About this study
Official title: Effect of Pulsatile and Non-Pulsatile Cardiopulmonary Bypass Flow on Choroidal Circulation in Diabetic and Non-Diabetic Patients
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.
Read the 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.
- Keywords
- Diabetic Retinopathy, Cardiopulmonary Bypass, Pulsatile Flow
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month after surgery
Secondary outcomes (3)
Change in Retinal Vascular Density (RVD)
RVD will be assessed by OCTA and measured as vessel density (%) at baseline and 1-month post-op, compared between study groups.
Measured: 1 month after surgery
Change in Foveal Avascular Zone (FAZ) Area
FAZ area will be measured preoperatively and 1 month postoperatively using OCTA, and compared across study groups.
Measured: 1 month after surgery
Comparison of CVI Change Between Diabetic and Non-Diabetic Patients
Subgroup analysis of CVI change will be performed to assess whether diabetes status affects choroidal perfusion response to CPB flow type.
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jan 2023
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Retinopathy (DR)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07034612
- Sponsor's protocol ID
- SamsunKVC OCT
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pulsatile and Non-Pulsatile Cardiopulmonary Bypass Flow on Choroidal Circulation in Diabetic and Non-Diabetic Patients
- ClinicalTrials.gov ID
- NCT07034612
- Acronym / sponsor ID
- SamsunKVC OCT
- Keywords
- Diabetic Retinopathy, Cardiopulmonary Bypass, Pulsatile Flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 24 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Change in Retinal Vascular Density (RVD)
Time frame: 1 month after surgery
Change in Foveal Avascular Zone (FAZ) Area
Time frame: 1 month after surgery
Comparison of CVI Change Between Diabetic and Non-Diabetic Patients
Time frame: 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy (DR) and Cardiopulmonary Bypass, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Choroidal Vascularity Index (CVI) from Baseline to 1-Month Postoperative (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.