Diabetic RetinopathyNCT04488887
OCTA Metrics Repeatability and Reproducibility in Different Disorders
An observational study of Diabetic Retinopathy and Myopia, run by Tanta University at 1 site in Egypt.
Trial summary
Retinal imaging is a corner stone in diagnosis of most retinal disorders. Standard imaging techniques e.g. fluorescein angiography and color fundus photography have a lot of limitations including limited resolution, invasive nature in cases of fluorescein angiography, and inability to segment the retina, accordingly… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetic Retinopathy, Myopia, Choroidal Neovascularization
- What is being tested?
- Optical coherence tomography angiography
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2020to 31 Jul 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Repeatability and reproducibility of the different OCTA metrics will be carried out in the following disorders; diabetic retinopathy, myopia, choroidal neovascularization, and in healthy controls for comparison.
Who may be able to join
- Patients 18 years or above, that fall in any of the study groups
- Clear media allowing for imaging
Who cannot join
- Maculopathies (hereditary or acquired)
- Optic nerve head pathologies (tilted disc, drusen, optic disc edema, atrophy, etc.)
- Optic neuropathies (demyelinating, infectious, ischemic, etc.),
- corneal edema and dense cataracts that can disrupt images
- history of vasoactive agents (calcium antagonists, nitric oxide, etc.)
- systemic diseases (vasculitis, diabetes mellitus, hypertension, etc.)
- Previous ocular surgery
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Ophthalmology Department, Faculty of medicine, Tanta Univeristy
Tanta, 31515
About this study
Official title: Evaluation of the Repeatability and Reproducibility of Different Quantitative Optical Coherence Tomography Angiography Metrics in Retinal Disorders
Retinal imaging is a corner stone in diagnosis of most retinal disorders. Standard imaging techniques e.g. fluorescein angiography and color fundus photography have a lot of limitations including limited resolution, invasive nature in cases of fluorescein angiography, and inability to segment the retina, accordingly, and only 2D image is provided.
Optical coherence tomography angiography (OCTA) is a recent noninvasive imaging technique that allows for volumetric visualization of eye vasculature. OCTA has shown promise in better elucidating the pathophysiology of several retinal vascular diseases. Swept-source OCTA uses long wavelength ̰ 1,050nm, which can penetrate through deeper layers of the eye and can traverse opacities of media such as cataracts, hemorrhages and vitreous opacities.
Read more
Optical coherence tomographic angiograms can further be manually or automatically segmented with preprogrammed software to highlight individual layers of the retina, optic nerve head choriocapillaris, and choroid. The user can either analyze en face images extending from the inner limiting membrane to choroid or use automated views to locate a vascular or structural lesion within the retina.
Different quantitative metrics has been extracted from enface OCTA images including vessel density, FAZ area, choriocapillaries flow deficit, intercapillary area and fractal dimension. These metrics are helpful in evaluation the retinal perfusion and used by physicians to assess various retinal vascular disorders.
Although some previous literatures had discussed the repeatability of OCTA metrics, however, comprehensive evaluation of widely used metrics in various retinal condition has not be done. Additionally, recent data suggest that various methods of calculation of these metrics my yield final different results of the same metric.
Read the detailed description
This will be prospective cross-sectional study. This research will be done in the period between 1 August and 31 December 2020 and will include 80 eyes from patients with following disorders:
Group 1: Patients with diabetic retinopathy Group 2: Patients with myopia Group 3: patients with choroidal neovascularization Group 4: control eyes with no retinal disease. Inclusion criteria: Patients above 18 years in age with any of above retinal condition and clear media allowing for imaging will be included.
Exclusion criteria will include; Maculopathies (hereditary or acquired), optic nerve head pathologies (tilted disc, drusen, optic disc edema, atrophy, etc.), optic neuropathies (demyelinating, infectious, ischemic, etc.), adjusted IOP for central corneal thickness more than 21 mmHg, surgery-induced corneal edema and dense cataracts that can disrupt images, history of vasoactive agents (calcium antagonists, nitric oxide, etc.) use, systemic diseases (vasculitis, diabetes mellitus, hypertension, etc.) and any previous ocular surgery, patients with bad quality images or complicated surgeries will be excluded.
All patients will be subject to Full ophthalmologic examination and OCTA imaging. High-quality 3 x 3 mm and 6 x 6 mm OCTA macular scans and 4.5 × 4.5-mm papillary scan with strong signal-noise ratio and adequate centration on the fovea and optic nerve head respectively will be selected.
For each patient 10 successive scans will be generated to allow for the analysis of repeatability. Patient will be imaged in the same day at two different OCTA devices Dri Triton (Topcon, Japan) and Cirrus OCT (Zeiss, USA) to investigate the reproducibility of the measurements.
Automated segmentation will be used to evaluate superficial and deep capillary retinal plexus projections. If errors in segmentation were detected, manual correction would be performed. The superficial retinal capillary plexus (SCP) was delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) was segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL). In addition, the total retinal capillary plexus (TCP) was manually customized by selecting the inner boundary at the ILM and the outer boundary set at 40 µm above the retinal pigment epithelium (RPE) to avoid any flow signals from choriocapillaries.
We will evaluate the following metric from enface OCT angiogram; vessel density, vessel density, intercapillary area, fractal dimension and skeletonized vessel density.
Every included patient in this study will have unique code number referring to the file where all his data will be kept confidential. Only macula and optic disc will be imaged. Additionally, patients' personal data will be hidden during using of these images. All patients' data will be used for scientific research only and will be kept totally confidential. Comprehensive explanation of all aspects of this study will be given to patients before their participation in it, an informed consent will be obtained from the patients before their enrolment in the study. Although no documented adverse effects from OCTA imaging on the patients to date, however, any unexpected risks appeared during the research will be cleared to the participants and the ethical committee on time.
Statistical analysis will be performed using SPSS software (version 25; SPSS, Inc., Chicago, IL, USA). the intraclass correlation coefficient (ICC) and coefficient of variation (CV) will be calculated. ICC is the correlation between two variables measured at the same time point, with values ranging from 0 to 1 (<0.40, poor; 0.40-0.59, fair; 0.60-0.74, good; 0.75-1.00, excellent). The CV (%) will be calculated as 100 × standard deviation/overall mean, and a value <10% represents good repeatability of the measurement.
- Conditions
- Diabetic Retinopathy, Myopia, Choroidal Neovascularization, Healthy
- Being tested
- Optical coherence tomography angiography
- Medical subject headings
- Diabetic Retinopathy, Myopia, Choroidal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomography angiographyDiagnostic test
patients in all groups will be examined with optical coherence tomography angiography, for every eye 3 macular and 3 papillary scans will be performed by two different OCTA machines, analysis will be carried out to evaluate the repeatability and reproducibility of the test
| Study group | Role | What they receive |
|---|---|---|
| Diabetic retinopathy Group | Patients with non-proliferative and proliferative diabetic retinopathy with clear media will be recruited. Receives: Diagnostic Test: Optical coherence tomography angiography | |
| Myopia Group | Patients with different grades of myopia, with accurate segmentation will be recruited Receives: Diagnostic Test: Optical coherence tomography angiography | |
| Choroidal neovascularization group | Patients with active choroidal vascularization without scarring will be recruited Receives: Diagnostic Test: Optical coherence tomography angiography | |
| Healthy controls | Healthy individuals without retinal disorders will be included for comaprison Receives: Diagnostic Test: Optical coherence tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intraclass correlation coefficient (ICC)
ICC is the correlation between two variables measured at the same time point, with values ranging from 0 to 1 (<0.40, poor; 0.40-0.59, fair; 0.60-0.74, good; 0.75-1.00, excellent).
Measured: 5 months
coefficient of variation (CV)
The CV (%) will be calculated as 100 × standard deviation/overall mean, and a value <10% represents good repeatability of the measurement.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Aug 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osama Abdelfattah Sorour, Tanta University
- Investigators
- Osama A Sorour, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488887
- Sponsor's protocol ID
- 33875/6/20
- Status last verified
- Jul 2020
- First submitted
- 24 Jul 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehta N, Liu K, Alibhai AY, Gendelman I, Braun PX, Ishibazawa A, Sorour O, Duker JS, Waheed NK. Impact of Binarization Thresholding and Brightness/Contrast Adjustment Methodology on Optical Coherence Tomography Angiography Image Quantification. Am J Ophthalmol. 2019 Sep;205:54-65. doi: 10.1016/j.ajo.2019.03.008. Epub 2019 Mar 15.
PubMed 30885708Byon I, Alagorie AR, Ji Y, Su L, Sadda SR. Optimizing the Repeatability of Choriocapillaris Flow Deficit Measurement From Optical Coherence Tomography Angiography. Am J Ophthalmol. 2020 Nov;219:21-32. doi: 10.1016/j.ajo.2020.05.027. Epub 2020 May 23.
PubMed 32454035
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Repeatability and Reproducibility of Different Quantitative Optical Coherence Tomography Angiography Metrics in Retinal Disorders
- ClinicalTrials.gov ID
- NCT04488887
- Acronym / sponsor ID
- 33875/6/20
- Conditions
- Diabetic Retinopathy, Myopia, Choroidal Neovascularization, Healthy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 28 Jul 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.
Retinal imaging is a corner stone in diagnosis of most retinal disorders. Standard imaging techniques e.g. fluorescein angiography and color fundus photography have a lot of limitations including limited resolution, invasive nature in cases of fluorescein angiography, and inability to segment the retina, accordingly, and only 2D image is provided.
Optical coherence tomography angiography (OCTA) is a recent noninvasive imaging technique that allows for volumetric visualization of eye vasculature. OCTA has shown promise in better elucidating the pathophysiology of several retinal vascular diseases. Swept-source OCTA uses long wavelength ̰ 1,050nm, which can penetrate through deeper layers of the eye and can traverse opacities of media such as cataracts, hemorrhages and vitreous opacities.
Optical coherence tomographic angiograms can further be manually or automatically segmented with preprogrammed software to highlight individual layers of the retina, optic nerve head choriocapillaris, and choroid. The user can either analyze en face images extending from the inner limiting membrane to choroid or use automated views to locate a vascular or structural lesion within the retina.
Different quantitative metrics has been extracted from enface OCTA images including vessel density, FAZ area, choriocapillaries flow deficit, intercapillary area and fractal dimension. These metrics are helpful in evaluation the retinal perfusion and used by physicians to assess various retinal vascular disorders.
Although some previous literatures had discussed the repeatability of OCTA metrics, however, comprehensive evaluation of widely used metrics in various retinal condition has not be done. Additionally, recent data suggest that various methods of calculation of these metrics my yield final different results of the same metric.
Detailed description
This will be prospective cross-sectional study. This research will be done in the period between 1 August and 31 December 2020 and will include 80 eyes from patients with following disorders:
Group 1: Patients with diabetic retinopathy Group 2: Patients with myopia Group 3: patients with choroidal neovascularization Group 4: control eyes with no retinal disease. Inclusion criteria: Patients above 18 years in age with any of above retinal condition and clear media allowing for imaging will be included.
Exclusion criteria will include; Maculopathies (hereditary or acquired), optic nerve head pathologies (tilted disc, drusen, optic disc edema, atrophy, etc.), optic neuropathies (demyelinating, infectious, ischemic, etc.), adjusted IOP for central corneal thickness more than 21 mmHg, surgery-induced corneal edema and dense cataracts that can disrupt images, history of vasoactive agents (calcium antagonists, nitric oxide, etc.) use, systemic diseases (vasculitis, diabetes mellitus, hypertension, etc.) and any previous ocular surgery, patients with bad quality images or complicated surgeries will be excluded.
All patients will be subject to Full ophthalmologic examination and OCTA imaging. High-quality 3 x 3 mm and 6 x 6 mm OCTA macular scans and 4.5 × 4.5-mm papillary scan with strong signal-noise ratio and adequate centration on the fovea and optic nerve head respectively will be selected.
For each patient 10 successive scans will be generated to allow for the analysis of repeatability. Patient will be imaged in the same day at two different OCTA devices Dri Triton (Topcon, Japan) and Cirrus OCT (Zeiss, USA) to investigate the reproducibility of the measurements.
Automated segmentation will be used to evaluate superficial and deep capillary retinal plexus projections. If errors in segmentation were detected, manual correction would be performed. The superficial retinal capillary plexus (SCP) was delineated with an inner boundary at the internal limiting membrane (ILM) and an outer boundary 10 µm inside the inner plexiform layer (IPL). The deep retinal capillary plexus (DCP) was segmented with an inner boundary 10 µm inside the IPL and an outer boundary at 10 µm beneath the outer plexiform layer (OPL). In addition, the total retinal capillary plexus (TCP) was manually customized by selecting the inner boundary at the ILM and the outer boundary set at 40 µm above the retinal pigment epithelium (RPE) to avoid any flow signals from choriocapillaries.
We will evaluate the following metric from enface OCT angiogram; vessel density, vessel density, intercapillary area, fractal dimension and skeletonized vessel density.
Every included patient in this study will have unique code number referring to the file where all his data will be kept confidential. Only macula and optic disc will be imaged. Additionally, patients' personal data will be hidden during using of these images. All patients' data will be used for scientific research only and will be kept totally confidential. Comprehensive explanation of all aspects of this study will be given to patients before their participation in it, an informed consent will be obtained from the patients before their enrolment in the study. Although no documented adverse effects from OCTA imaging on the patients to date, however, any unexpected risks appeared during the research will be cleared to the participants and the ethical committee on time.
Statistical analysis will be performed using SPSS software (version 25; SPSS, Inc., Chicago, IL, USA). the intraclass correlation coefficient (ICC) and coefficient of variation (CV) will be calculated. ICC is the correlation between two variables measured at the same time point, with values ranging from 0 to 1 (<0.40, poor; 0.40-0.59, fair; 0.60-0.74, good; 0.75-1.00, excellent). The CV (%) will be calculated as 100 × standard deviation/overall mean, and a value <10% represents good repeatability of the measurement.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diabetic retinopathy Group | – | Diagnostic Test: Optical coherence tomography angiographyPatients with non-proliferative and proliferative diabetic retinopathy with clear media will be recruited. |
| Myopia Group | – | Diagnostic Test: Optical coherence tomography angiographyPatients with different grades of myopia, with accurate segmentation will be recruited |
| Choroidal neovascularization group | – | Diagnostic Test: Optical coherence tomography angiographyPatients with active choroidal vascularization without scarring will be recruited |
| Healthy controls | – | Diagnostic Test: Optical coherence tomography angiographyHealthy individuals without retinal disorders will be included for comaprison |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Repeatability and reproducibility of the different OCTA metrics will be carried out in the following disorders; diabetic retinopathy, myopia, choroidal neovascularization, and in healthy controls for comparison.
Key inclusion criteria (2 listed)
- Patients 18 years or above, that fall in any of the study groups
- Clear media allowing for imaging
Key exclusion criteria (7 listed)
- Maculopathies (hereditary or acquired)
- Optic nerve head pathologies (tilted disc, drusen, optic disc edema, atrophy, etc.)
- Optic neuropathies (demyelinating, infectious, ischemic, etc.),
- corneal edema and dense cataracts that can disrupt images
- history of vasoactive agents (calcium antagonists, nitric oxide, etc.)
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 tomography angiographypatients in all groups will be examined with optical coherence tomography angiography, for every eye 3 macular and 3 papillary scans will be performed by two different OCTA machines, analysis will be carried out to evaluate the repeatability and reproducibility of the test | Diagnostic test | Choroidal neovascularization group, Diabetic retinopathy Group, Healthy controls, Myopia Group |
Primary outcome
The intraclass correlation coefficient (ICC)
Time frame: 5 months
ICC is the correlation between two variables measured at the same time point, with values ranging from 0 to 1 (<0.40, poor; 0.40-0.59, fair; 0.60-0.74, good; 0.75-1.00, excellent).
coefficient of variation (CV)
Time frame: 5 months
The CV (%) will be calculated as 100 × standard deviation/overall mean, and a value <10% represents good repeatability of the measurement.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Background: PubMed 30885708Mehta N, Liu K, Alibhai AY, Gendelman I, Braun PX, Ishibazawa A, Sorour O, Duker JS, Waheed NK. Impact of Binarization Thresholding and Brightness/Contrast Adjustment Methodology on Optical Coherence Tomography Angiography Image Quantification. Am J Ophthalmol. 2019 Sep;205:54-65. doi: 10.1016/j.ajo.2019.03.008. Epub 2019 Mar 15.
- Background: PubMed 32454035Byon I, Alagorie AR, Ji Y, Su L, Sadda SR. Optimizing the Repeatability of Choriocapillaris Flow Deficit Measurement From Optical Coherence Tomography Angiography. Am J Ophthalmol. 2020 Nov;219:21-32. doi: 10.1016/j.ajo.2020.05.027. Epub 2020 May 23.
- Individual participant dataSharing planned: No
Related trials for Diabetic Retinopathy
Active, not recruitingObservational study
Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT)
Diabetic Macular Edema, Diabetic Retinopathy
Not yet recruitingObservational study
A Case-Control Study Revealing Intraocular Microenvironment Characteristics in Patients With Ocular Diseases Based on Multi-Omics Analysis
Age- Related Macular Degeneration, Diabetic Retinopathy
RecruitingPhase 2
A Randomized, Phase 2 Study of Oral BGE-102 in Participants With Center-Involved Diabetic Macular Edema
Diabetic Macular Edema (DME)
RecruitingObservational study
National Eye Institute Biorepository for Retinal Diseases
Age-Related Macular Degeneration, Diabetic Retinopathy
RecruitingObservational study
Human iPSC for Repair of Vasodegenerative Vessels in Diabetic Retinopathy
Diabetes Complications, Diabetic Retinopathy
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.
Osama A Sorour, MD principal investigator
Tanta 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 and Myopia, run by Tanta University at 1 site in Egypt.
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 2 inclusion and 7 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 28 Jul 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 Egypt. 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 Rauof A Gaber (+201012292208, dr.osamasorour@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The intraclass correlation coefficient (ICC) (time frame: 5 months). 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?
On the ClinicalTrials.gov record for NCT04488887, which also lists 2 linked publications.
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 28 Jul 2020.