Diabetic RetinopathyNCT04637217
Retinal Neurodegenerative and Vascular Changes in Diabetic Patients
An observational study of Diabetic Retinopathy and Neurodegeneration, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Using Optical Coherence Tomography and ImageJ software the investigators will analyze retinal and choroidal vascular changes and their impact on retinal layers among patients with diabetes without retinopathy and patients with diabetes and retinopathy. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy, Neurodegeneration
- What is being tested?
- Optical Coherence Tomography
- How many people
- 97 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jul 2018to 1 Jul 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All participants were recruited between July 2018 and July 2019 at Department of Ophthalmology, Emergency County Hospital Cluj, Romania. Healthy subjects were recruited from patients scheduled for routine ocular examination at Department of Ophthalmology, Emergency County Hospital Cluj, Romania
Who may be able to join
- history of type 1DM for more than 1 year
- history of type 2 DM for more than 3 months
- diagnosis of no DR or mild Non-proliferative diabetic retinopathy(NPDR)
Who cannot join
- DR with more than NPDR ,
- Diabetic macular oedema,
- media opacities such as corneal or lens opacities that could preclude appropriate OCT imaging,
- presence of other retinal diseases such as Age-related macular degeneration, Vitreo-macular traction, Macular hole, Epiretinal membrane, Retinal vein occlusion, Macular scars,
- Glaucoma, Optic neuropathies or Neurodegenerative diseases,
- history of ocular trauma,
- Refractive errors of more than ±6 diopters (spherical equivalent),
- previous ocular surgery, focal laser, panretinal photocoagulation or anti-VEGF intravitreal injection
Trial locations and contacts
1 site in 1 country.
Romania1 site
University of Medicine and Pharmacy " Iuliu Hatieganu"
Cluj-Napoca
About this study
Official title: Retinal Neurodegenerative and Vascular Changes in Diabetic Patients: an OCT-based Comparative Study
Using Optical Coherence Tomography and ImageJ software the investigators will analyze retinal and choroidal vascular changes and their impact on retinal layers among patients with diabetes without retinopathy and patients with diabetes and retinopathy.
Read the detailed description
Relieving the burden of diabetic retinopathy treatment require a prompt and non-invasive assessment of diabetic patients before the occurence of diabetic retinopathy. Since OCT is capable of imaging retina with such a high precision, retinal changes occuring before any clinical signs of retinopathy, such as microaneurysm or haemorrhages, can now be assessed. In the present study the investigators are analyzing the connection between retinal arteries and veins regarding lumen diameter, vessel wall thickness and their correlation with retinal nerve fiber layer and ganglion cell layer thickness. Moreover, using binarization of the choroid the investigators will assess its relationship with outer retina layers, such as retinal pigment epithelium and photoreceptors.
- Conditions
- Diabetic Retinopathy, Neurodegeneration
- Being tested
- Optical Coherence Tomography
- Keywords
- optical coherence tomography, choroid, outer retina
- Medical subject headings
- Diabetic Retinopathy, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDiagnostic test
Spectral Domain Optical Coherence Tomography(SD-OCT) examination will be performed for every patient: posterior pole scan, EDI-OCT(enhanced depth imaging-OCT) and peripapillary RNFL(retinal nerve fiber layer)
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described Receives: Diagnostic Test: Optical Coherence Tomography | |
| Diabetes mellitus without Diabetic Retinopathy | Not described Receives: Diagnostic Test: Optical Coherence Tomography | |
| Diabetes mellitus with Diabetic Retinopathy | Not described Receives: Diagnostic Test: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between choroid and outer retina using SD-OCT- based binarization technique
starting from EDI-OCT scans the investigators will analyze choroidal parameters such as Luminal area, Stromal area, Total choroidal area, Chorodial vascularity index and correlate them with retinal pigment epithelium (RPE),outer nuclear layer(ONL) and photoreceptors' thickness (PR)
Measured: 2018-2019
Correlation between neurodegeneration and retinal vessels characteristics
using full width at half maximum method, the investigators will measure peripapillary arteries and veins' diameters, their wall thickness and correlate them with RNFL and ganglion cell layer(GCL) thickness
Measured: 2018-2019
Secondary outcomes (4)
Correlation between choroidal parameters and their influence on Best corrected visual acuity(BCVA)
The investigators will analyze if changes in the choroid will influence patients' visual acuity. For statistical reasons, visual acuity will be converted to logMAR(logarithm of the minimum angle of resolution)
Measured: 2018-2019
Correlation between renal function and choroidal parameters
Using estimated glomerular filtration rate(eGFR-mL/min/1.73 m2) the investigators will analyze if a decreased eGFR will produce changes in choroidal architecture
Measured: 2018-2019
Correlation between sistemic factors and choroidal parameters
The investigators will document if the presence of High Blood pressure(yes/no) and current smoking(yes/no) influences choroidal thickness or CVI.
Measured: 2018-2019
Correlation between choroidal parameters and diabetes control
Using HbA1c(Glycated haemoglobin) the investigators will analyze the choroidal's behaviour under different HbA1c levels.
Measured: 2018-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Jul 2018
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
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
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ioana Damian, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Ioana Damian, MD, Principal investigator, Iuliu Hatieganu University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637217
- Sponsor's protocol ID
- U1111-1249-7228
- Status last verified
- Nov 2020
- First submitted
- 12 Nov 2020
- Last updated
- 19 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retinal Neurodegenerative and Vascular Changes in Diabetic Patients: an OCT-based Comparative Study
- ClinicalTrials.gov ID
- NCT04637217
- Acronym / sponsor ID
- U1111-1249-7228
- Conditions
- Diabetic Retinopathy, Neurodegeneration
- Keywords
- optical coherence tomography, choroid, outer retina
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 19 Nov 2020 (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.
Using Optical Coherence Tomography and ImageJ software the investigators will analyze retinal and choroidal vascular changes and their impact on retinal layers among patients with diabetes without retinopathy and patients with diabetes and retinopathy.
Detailed description
Relieving the burden of diabetic retinopathy treatment require a prompt and non-invasive assessment of diabetic patients before the occurence of diabetic retinopathy. Since OCT is capable of imaging retina with such a high precision, retinal changes occuring before any clinical signs of retinopathy, such as microaneurysm or haemorrhages, can now be assessed. In the present study the investigators are analyzing the connection between retinal arteries and veins regarding lumen diameter, vessel wall thickness and their correlation with retinal nerve fiber layer and ganglion cell layer thickness. Moreover, using binarization of the choroid the investigators will assess its relationship with outer retina layers, such as retinal pigment epithelium and photoreceptors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Diagnostic Test: Optical Coherence Tomography |
| Diabetes mellitus without Diabetic Retinopathy | – | Diagnostic Test: Optical Coherence Tomography |
| Diabetes mellitus with Diabetic Retinopathy | – | Diagnostic Test: Optical Coherence Tomography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants were recruited between July 2018 and July 2019 at Department of Ophthalmology, Emergency County Hospital Cluj, Romania. Healthy subjects were recruited from patients scheduled for routine ocular examination at Department of Ophthalmology, Emergency County Hospital Cluj, Romania
Key inclusion criteria (3 listed)
- history of type 1DM for more than 1 year
- history of type 2 DM for more than 3 months
- diagnosis of no DR or mild Non-proliferative diabetic retinopathy(NPDR)
Key exclusion criteria (8 listed)
- DR with more than NPDR ,
- Diabetic macular oedema,
- media opacities such as corneal or lens opacities that could preclude appropriate OCT imaging,
- presence of other retinal diseases such as Age-related macular degeneration, Vitreo-macular traction, Macular hole, Epiretinal membrane, Retinal vein occlusion, Macular scars,
- Glaucoma, Optic neuropathies or Neurodegenerative diseases,
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 |
|---|---|---|
| Optical Coherence TomographySpectral Domain Optical Coherence Tomography(SD-OCT) examination will be performed for every patient: posterior pole scan, EDI-OCT(enhanced depth imaging-OCT) and peripapillary RNFL(retinal nerve fiber layer) | Diagnostic test | Control, Diabetes mellitus with Diabetic Retinopathy, Diabetes mellitus without Diabetic Retinopathy |
Primary outcome
Correlation between choroid and outer retina using SD-OCT- based binarization technique
Time frame: 2018-2019
starting from EDI-OCT scans the investigators will analyze choroidal parameters such as Luminal area, Stromal area, Total choroidal area, Chorodial vascularity index and correlate them with retinal pigment epithelium (RPE),outer nuclear layer(ONL) and photoreceptors' thickness (PR)
Correlation between neurodegeneration and retinal vessels characteristics
Time frame: 2018-2019
using full width at half maximum method, the investigators will measure peripapillary arteries and veins' diameters, their wall thickness and correlate them with RNFL and ganglion cell layer(GCL) thickness
4 secondary outcomes
Correlation between choroidal parameters and their influence on Best corrected visual acuity(BCVA)
Time frame: 2018-2019
Correlation between renal function and choroidal parameters
Time frame: 2018-2019
Correlation between sistemic factors and choroidal parameters
Time frame: 2018-2019
Correlation between choroidal parameters and diabetes control
Time frame: 2018-2019
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 19 Nov 2020.
- Individual participant dataSharing planned: Yes
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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.
Ioana Damian, MD principal investigator
Iuliu Hatieganu University of Medicine and Pharmacy
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 and Neurodegeneration, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 3 inclusion and 8 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 19 Nov 2020. 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 Romania. 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?
Correlation between choroid and outer retina using SD-OCT- based binarization technique (time frame: 2018-2019). The study lists 2 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 19 Nov 2020.