Open Angle GlaucomaNCT06214676
OCTA in Patients With Primary Open-angle Glaucoma
An observational study of Open Angle Glaucoma, run by Assiut University.
Trial summary
Is to investigate retinal microvascular changes in primary open angle glaucoma patients using Optical Coherence Tomography Angiography. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- OCT angiography
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2024to Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary open angle patients presented to El Nour Eye Center data will be collected by scientifically qualified and trained resident doctors using Optical Coherence Tomography Angiography ( solix)
Who may be able to join
- clinical diagnosis of Primary open angle glaucoma.
Who cannot join
- media opacity
- poor fixation due to advanced disease
- associated vascular retinopathy
- chronic uveitis
- optic nerve disease due to other etiologies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Detection of Microvascular Changes in Patients With Primary Open Angle Glaucoma by Using Optical Coherence Tomography Angiography
Is to investigate retinal microvascular changes in primary open angle glaucoma patients using Optical Coherence Tomography Angiography.
Read the detailed description
Optical coherence tomography angiography (OCT-A) is a non-invasive imaging technique developed to visualize vascular networks in the retina and choroid. It utilizes low-coherence interferometry to measure changes in backscattered signal to differentiate areas of blood flow from areas of static tissue.
OCTA provides both structural and functional (i.e. blood flow) information in tandem. The "corresponding" OCT b-scans can be co-registered with the simultaneous OCT angiograms so the operator is able to scroll through the OCT angiogram like a cube scan. As a result, the precise location of pathology can be viewed on the corresponding OCT b-scans. This makes OCTA a better tool when detecting the exact location of a retinal pathology.
Glaucoma is the first cause of irreversible blindness and represents approximately 15% of all causes of blindness . This makes it a real public health problem. In 2020, glaucoma affected about 80 million people worldwide, with nearly 75% of open-angle glaucoma Primary open-angle glaucoma (POAG) is a chronic, progressive, blinding, irreversible optic neuropathy characterized by damage to the optic nerve head and retinal nerve fibers with subsequent visual field defects ,elevated intraocular pressure (IOP) is a crucial glaucoma risk factor that causes direct damage to RGCs and the optic nerve . Moreover, glaucomatous retinsl ganglion cells loss occurs as well in people with normal IOP, implying mechanisms behind pressure-mediated damage. RGCs death may be due to the reduced blood supply and microvasculature dysfunction may be essential in glaucoma pathogenesis .
One hypothesis is that POAG is categorized by impaired chemical endothelial signaling between both: a) the inner wall Schlemm's canal endothelial cells as well as endothelial cells located in the ciliary body and the posterior longitudinal muscle that helps to set outflow resistance and b) the ocular vascular endothelial cell and underlying luminal smooth muscle for vessels supplying the retinal ganglion cells (RGCs). This hypothesis could explain why POAG occurs across a spectrum of IOP but it does not consider the role systemic endothelial cell dysfunction may play in the disease.
The non-invasive technique of OCT angiography (OCTA) can image and quantify both large vessels and the microvasculature of the optic nerve head (ONH), retina and choroid layers . Using the OCTA technique, reduced vessel density (VD) was observed in the ONH, peripapillary area and macula, predominantly in primary open-angle glaucoma (POAG)
- Conditions
- Open Angle Glaucoma
- Being tested
- OCT angiography
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT angiographyDevice
Detection of microvascular changes in patients with primary open angle glaucoma by using Optical Coherence Tomography Angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
to detect and evaluate microvascular changes in primary open angle glaucoma both qualitatively and quantitatively.
Detection of microvascular changes in patients with Primary open-angle glaucoma
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2024
- Study startApr 2024 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yara Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06214676
- Sponsor's protocol ID
- OCTA in glaucoma
- Status last verified
- Mar 2024
- First submitted
- 10 Jan 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Microvascular Changes in Patients With Primary Open Angle Glaucoma by Using Optical Coherence Tomography Angiography
- ClinicalTrials.gov ID
- NCT06214676
- Acronym / sponsor ID
- OCTA in glaucoma
- Conditions
- Open Angle Glaucoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2024 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 19 Jan 2024 (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.
Is to investigate retinal microvascular changes in primary open angle glaucoma patients using Optical Coherence Tomography Angiography.
Detailed description
Optical coherence tomography angiography (OCT-A) is a non-invasive imaging technique developed to visualize vascular networks in the retina and choroid. It utilizes low-coherence interferometry to measure changes in backscattered signal to differentiate areas of blood flow from areas of static tissue.
OCTA provides both structural and functional (i.e. blood flow) information in tandem. The "corresponding" OCT b-scans can be co-registered with the simultaneous OCT angiograms so the operator is able to scroll through the OCT angiogram like a cube scan. As a result, the precise location of pathology can be viewed on the corresponding OCT b-scans. This makes OCTA a better tool when detecting the exact location of a retinal pathology.
Glaucoma is the first cause of irreversible blindness and represents approximately 15% of all causes of blindness . This makes it a real public health problem. In 2020, glaucoma affected about 80 million people worldwide, with nearly 75% of open-angle glaucoma Primary open-angle glaucoma (POAG) is a chronic, progressive, blinding, irreversible optic neuropathy characterized by damage to the optic nerve head and retinal nerve fibers with subsequent visual field defects ,elevated intraocular pressure (IOP) is a crucial glaucoma risk factor that causes direct damage to RGCs and the optic nerve . Moreover, glaucomatous retinsl ganglion cells loss occurs as well in people with normal IOP, implying mechanisms behind pressure-mediated damage. RGCs death may be due to the reduced blood supply and microvasculature dysfunction may be essential in glaucoma pathogenesis .
One hypothesis is that POAG is categorized by impaired chemical endothelial signaling between both: a) the inner wall Schlemm's canal endothelial cells as well as endothelial cells located in the ciliary body and the posterior longitudinal muscle that helps to set outflow resistance and b) the ocular vascular endothelial cell and underlying luminal smooth muscle for vessels supplying the retinal ganglion cells (RGCs). This hypothesis could explain why POAG occurs across a spectrum of IOP but it does not consider the role systemic endothelial cell dysfunction may play in the disease.
The non-invasive technique of OCT angiography (OCTA) can image and quantify both large vessels and the microvasculature of the optic nerve head (ONH), retina and choroid layers . Using the OCTA technique, reduced vessel density (VD) was observed in the ONH, peripapillary area and macula, predominantly in primary open-angle glaucoma (POAG)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary open angle patients presented to El Nour Eye Center data will be collected by scientifically qualified and trained resident doctors using Optical Coherence Tomography Angiography ( solix)
Key inclusion criteria (1 listed)
- clinical diagnosis of Primary open angle glaucoma.
Key exclusion criteria (5 listed)
- media opacity
- poor fixation due to advanced disease
- associated vascular retinopathy
- chronic uveitis
- optic nerve disease due to other etiologies
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 |
|---|---|---|
| OCT angiographyDetection of microvascular changes in patients with primary open angle glaucoma by using Optical Coherence Tomography Angiography | Device | – |
Primary outcome
to detect and evaluate microvascular changes in primary open angle glaucoma both qualitatively and quantitatively.
Time frame: Baseline
Detection of microvascular changes in patients with Primary open-angle glaucoma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma, 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 5 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 7 Mar 2024. 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 Yara Ahmed (01062165361, ayara1942@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to detect and evaluate microvascular changes in primary open angle glaucoma both qualitatively and quantitatively. (time frame: Baseline). 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 7 Mar 2024.