Diabetic RetinopathyNCT05902650
Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Mingzhe Cao at 1 site in China.
Trial summary
All OCTA data and biochemical indexes of diabetic patients were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- imaging
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: diabetic patients
Who may be able to join
- Clinical diagnosis of diabetes
Who cannot join
- various other types of retinal and choroidal disease;
- history of any intraocular surgery or treatment (including intravitreal injection, retinal photocoagulation etc.
- with severe refractive medium opacity that could affect fundus examination.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Seventh Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, 518000
Kuiqing Lu, 075581207047, lukq@mail.sysu.edu.cn
About this study
All OCTA data and biochemical indexes of diabetic patients were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.
Read the detailed description
Diabetic patients at the Department of Ophthalmology of the Seventh Affiliated Hospital of Sun Yat-sen University were selected as research participants. All OCTA data and biochemical indexes were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.
- Conditions
- Diabetic Retinopathy
- Being tested
- imaging
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imagingDiagnostic test
imaging
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | diabetic patients with no diabetic retinopathy Receives: Diagnostic Test: imaging | |
| Group 2 | diabetic patients with mild nonproliferative diabetic retinopathy Receives: Diagnostic Test: imaging | |
| Group 3 | diabetic patients with moderate and severe nonproliferative diabetic retinopathy Receives: Diagnostic Test: imaging | |
| Group 4 | diabetic patients with proliferative diabetic retinopathy Receives: Diagnostic Test: imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting blood glucose (FBG)
biochemical indexes
Measured: the time of the patient's first 1 day visit
glycosylated hemoglobin (HbAlc)
biochemical indexes
Measured: the time of the patient's first 1 day visit
OCTA data
An image of the 3mm×3mm and 6 mm×6 mm macular areas detected by OCTA were captured. Quantitative analysis of vascular density and perfusion density of superficial capillary plexus in the macular area were automatically calculated using built-in software on the device.
Measured: the time of the patient's first 1 day visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingzhe Cao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingzhe Cao, The Seventh Affiliated Hospital of Sun Yat-sen University
- Investigators
- Mingzhe Cao, Principal investigator, The Seventh Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05902650
- Sponsor's protocol ID
- MCao
- Status last verified
- Jun 2023
- First submitted
- 1 Jun 2023
- Last updated
- 15 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The research has not been completed.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Biochemical Indexes and Retinal Hemodynamic in Patients With Different Degrees of Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT05902650
- Acronym / sponsor ID
- MCao
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Mingzhe CaoUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Jun 2023 (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.
All OCTA data and biochemical indexes of diabetic patients were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.
Detailed description
Diabetic patients at the Department of Ophthalmology of the Seventh Affiliated Hospital of Sun Yat-sen University were selected as research participants. All OCTA data and biochemical indexes were acquired. A prediction model of diabetic retinopathy was built, and the random forest method was used to identify sensitive indicators.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Diagnostic Test: imagingdiabetic patients with no diabetic retinopathy |
| Group 2 | – | Diagnostic Test: imagingdiabetic patients with mild nonproliferative diabetic retinopathy |
| Group 3 | – | Diagnostic Test: imagingdiabetic patients with moderate and severe nonproliferative diabetic retinopathy |
| Group 4 | – | Diagnostic Test: imagingdiabetic patients with proliferative diabetic retinopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- diabetic patients
Key inclusion criteria (1 listed)
- Clinical diagnosis of diabetes
Key exclusion criteria (3 listed)
- various other types of retinal and choroidal disease;
- history of any intraocular surgery or treatment (including intravitreal injection, retinal photocoagulation etc.
- with severe refractive medium opacity that could affect fundus examination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| imagingimaging | Diagnostic test | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
fasting blood glucose (FBG)
Time frame: the time of the patient's first 1 day visit
biochemical indexes
glycosylated hemoglobin (HbAlc)
Time frame: the time of the patient's first 1 day visit
biochemical indexes
OCTA data
Time frame: the time of the patient's first 1 day visit
An image of the 3mm×3mm and 6 mm×6 mm macular areas detected by OCTA were captured. Quantitative analysis of vascular density and perfusion density of superficial capillary plexus in the macular area were automatically calculated using built-in software on the device.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2023.
- Individual participant dataSharing planned: Undecided. The research has not been completed.
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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.
Mingzhe Cao principal investigator
The Seventh Affiliated Hospital of Sun Yat-sen University
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, run by Mingzhe Cao at 1 site in China.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 15 Jun 2023. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mingzhe Cao, Dr. (13060822790, zhengz@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fasting blood glucose (FBG) (time frame: the time of the patient's first 1 day visit). The study lists 3 primary outcomes in all. 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 15 Jun 2023.