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AzTrials

Open Angle GlaucomaNCT06214676

OCTA in Patients With Primary Open-angle Glaucoma

An observational study of Open Angle Glaucoma, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Abd El Nasser Mohammad contact

01064747230

abdelnasser@aun.edu.eg

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)

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.

  1. 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.

  1. First posted19 Jan 2024
  2. Study startApr 2024 (estimated)
  3. Primary completionJan 2025 (estimated)
  4. Study completionFeb 2025 (estimated)

Resources

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)
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

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.

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