OctA .FFA Findings in DRNCT05190965
Optical Coherence Tomography Angiography and in Fluorescein Angiography in Diabetic Retinopathy
An observational study of OctA .FFA Findings in DR, run by Assiut University.
Trial summary
Diabetic retinopathy (DR) is the leading cause of decreased vision in working age people. Patients with DR can develop macular edema and proliferative retinopathy which are major causes of visual impairment [1]. The potential of OCTA regarding diagnosis and follow up of DR has been shown in previous studies [2-4]. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- OctA .FFA Findings in DR
- What is being tested?
- OCTAngiography .FFangiography
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Feb 2024
- 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 45 to 75 years
- All sexes
- Adult, Older adult
Study population: All included patients are planned to have FFA and OCTA en face 3x3mm
Who may be able to join
- All Pts with confirmed type 2 diabetes of at least 6 months. Best corrected visual Acuity of 6/60 or higher (using asnellen chart) in each eye
Who cannot join
- Dense media opacities interfere with image FFA as dense cataract . Previous TTT mainly retinal laser photocoagulation or intra vitreal injection. History of ocular disease as glaucoma and retinal vascular occlusion . Previous ocular surgery.
Trial locations and contacts
No sites are listed yet.
Wael Prof Mohamed Ahmed Soliman contact
About this study
Official title: Comparison Between Findings in Optical Coherence Tomography Angiography and in Fluorescein Angiography in Patients With Diapetic Retinopathy
Diabetic retinopathy (DR) is the leading cause of decreased vision in working age people. Patients with DR can develop macular edema and proliferative retinopathy which are major causes of visual impairment [1]. The potential of OCTA regarding diagnosis and follow up of DR has been shown in previous studies [2-4]. At present fluorescein angiography (FA) represents the gold standard in the diagnosis and staging of DR [5]. With FA vascular lesions like micro aneurysms (MAs), the size of areas of non-perfusion and of the foveal avascular zone (FAZ) and retinal neovascularisations can be reliably identified [6]. Al-though the capabilities of FA are well known, its use also contains some risks related to the intravenous injection of the dye, which can cause nausea, vomiting and allergic re actions and even anaphylactic shock [7]. Besides that, it also requires time and trained personnel [8]. Image acquisition by OCTA in contrast is not as time consuming and can be performed without taking any risks. Additionally, it provides a 3 dimensional cross sectional view of the retinal and choroidal layers with micro meter depth resolution, providing depth selective information of the retinal vasculature. This facilitates accurate diagnosis and follow up of retinal vascular diseases since significant insights into both morphology and perfusion status can be obtained simultaneously. Although various artifacts appear in OCTA images, a qualitative assessment is mostly possible [9].Early changes to be seen in OCTA in patients with non-proliferative DR are vascular remodelling bordering the FAZ, vascular tortuosity, narrowing of capillary lumen and capillary dilatation. These changes cannot be seen in the same manner in FA [10].In this study we investigated the size of the FAZ and the count of MAs in patients with DR.
- Conditions
- OctA .FFA Findings in DR
- Being tested
- OCTAngiography .FFangiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTAngiography .FFangiographyDevice
octa.ffa findings in pts with diapetic retinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare findings in OCTA.Ffa in DR
Number of microaneurysm.degree of ischemia.size of FAZ
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Feb 2024 (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 OctA .FFA Findings in DRStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Reda Mohamed Mahmoud, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190965
- Sponsor's protocol ID
- FFDR
- Status last verified
- Dec 2021
- First submitted
- 29 Dec 2021
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Klein R, Moss SE, Klein BE, Davis MD, DeMets DL. Wisconsin Epidemiologic Study of Diabetic Retinopathy. XII. Relationship of C-peptide and diabetic retinopathy. Diabetes. 1990 Nov;39(11):1445-50. doi: 10.2337/diab.39.11.1445.
PubMed 2121570Ghasemi Falavarjani K, Al-Sheikh M, Akil H, Sadda SR. Image artefacts in swept-source optical coherence tomography angiography. Br J Ophthalmol. 2017 May;101(5):564-568. doi: 10.1136/bjophthalmol-2016-309104. Epub 2016 Jul 20.
PubMed 27439739
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Findings in Optical Coherence Tomography Angiography and in Fluorescein Angiography in Patients With Diapetic Retinopathy
- ClinicalTrials.gov ID
- NCT05190965
- Acronym / sponsor ID
- FFDR
- Conditions
- OctA .FFA Findings in DR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 13 Jan 2022 (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.
Diabetic retinopathy (DR) is the leading cause of decreased vision in working age people. Patients with DR can develop macular edema and proliferative retinopathy which are major causes of visual impairment [1]. The potential of OCTA regarding diagnosis and follow up of DR has been shown in previous studies [2-4]. At present fluorescein angiography (FA) represents the gold standard in the diagnosis and staging of DR [5]. With FA vascular lesions like micro aneurysms (MAs), the size of areas of non-perfusion and of the foveal avascular zone (FAZ) and retinal neovascularisations can be reliably identified [6]. Al-though the capabilities of FA are well known, its use also contains some risks related to the intravenous injection of the dye, which can cause nausea, vomiting and allergic re actions and even anaphylactic shock [7]. Besides that, it also requires time and trained personnel [8]. Image acquisition by OCTA in contrast is not as time consuming and can be performed without taking any risks. Additionally, it provides a 3 dimensional cross sectional view of the retinal and choroidal layers with micro meter depth resolution, providing depth selective information of the retinal vasculature. This facilitates accurate diagnosis and follow up of retinal vascular diseases since significant insights into both morphology and perfusion status can be obtained simultaneously. Although various artifacts appear in OCTA images, a qualitative assessment is mostly possible [9].Early changes to be seen in OCTA in patients with non-proliferative DR are vascular remodelling bordering the FAZ, vascular tortuosity, narrowing of capillary lumen and capillary dilatation. These changes cannot be seen in the same manner in FA [10].In this study we investigated the size of the FAZ and the count of MAs in patients with DR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All included patients are planned to have FFA and OCTA en face 3x3mm
Key inclusion criteria (1 listed)
- All Pts with confirmed type 2 diabetes of at least 6 months. Best corrected visual Acuity of 6/60 or higher (using asnellen chart) in each eye
Key exclusion criteria (1 listed)
- Dense media opacities interfere with image FFA as dense cataract . Previous TTT mainly retinal laser photocoagulation or intra vitreal injection. History of ocular disease as glaucoma and retinal vascular occlusion . Previous ocular surgery.
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 |
|---|---|---|
| OCTAngiography .FFangiographyocta.ffa findings in pts with diapetic retinopathy | Device | – |
Primary outcome
Compare findings in OCTA.Ffa in DR
Time frame: Baseline
Number of microaneurysm.degree of ischemia.size of FAZ
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Background: PubMed 2121570Klein R, Moss SE, Klein BE, Davis MD, DeMets DL. Wisconsin Epidemiologic Study of Diabetic Retinopathy. XII. Relationship of C-peptide and diabetic retinopathy. Diabetes. 1990 Nov;39(11):1445-50. doi: 10.2337/diab.39.11.1445.
- Background: PubMed 27439739Ghasemi Falavarjani K, Al-Sheikh M, Akil H, Sadda SR. Image artefacts in swept-source optical coherence tomography angiography. Br J Ophthalmol. 2017 May;101(5):564-568. doi: 10.1136/bjophthalmol-2016-309104. Epub 2016 Jul 20.
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.
Wael Prof Mohamed Ahmed Soliman contact
Questions about this trial
What is this clinical trial studying?
An observational study of OctA .FFA Findings in DR, run by Assiut University.
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 1 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 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Esraa Resident Reda Mohamed (01092564344, esraareda54321@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare findings in OCTA.Ffa in DR (time frame: Baseline). 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 NCT05190965, 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 13 Jan 2022.