Visual FieldNCT06978101
Visual Field Changes and OCT Angiographic Chorioretinal Changes in Patients With Primary Open Angle Glaucoma
An observational study of Visual Field and OCT Angiography, run by Assiut University at 1 site in Egypt.
Trial summary
This study aimed to assess the correlation between visual field changes and optical coherence tomography (OCT) angiography changes of retinal nerve fiber layer in patients with primary open angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Visual Field, OCT Angiography, Chorioretinal Changes
- What is being tested?
- POAG group
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2021to 30 Dec 2023
- How long will I take part?
- 12 Months
- 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
- No healthy volunteers
- Adult, Older adult
Study population: This prospective cohort nonrandomized trial was carried out on 100 cases with primary open-angle glaucoma (POAG) group (n=80): had intraocular pressure (IOP)>21 mmHg, and control group (n=20): without family history of POAG, IOP ˂21mm Hg.
Who may be able to join
- Primary open angle glaucoma patients.
Who cannot join
- Hazy media.
- Diabetic Retinopathy.
- Uveitis.
- Other Glaucomas
- Acute congestive glaucoma
- Secondary glaucomas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Visual Field Changes and OCT Angiographic Chorioretinal Changes in Patients With Primary Open Angle Glaucoma
This study aimed to assess the correlation between visual field changes and optical coherence tomography (OCT) angiography changes of retinal nerve fiber layer in patients with primary open angle glaucoma.
Read the detailed description
Glaucoma is the leading cause of irreversible blindness worldwide. Since glaucomatous damage is preventable but irreversible, an early diagnosis and close follow-up of glaucoma patients are primordial. Optical coherence tomography angiography (OCTA) is a recently developed, noninvasive imaging modality that detects blood flow through the motion contrast generated by red blood cells.
Currently, there are 2 groups of complementary exams used for the diagnosis and follow-up of glaucoma patients: structural (where OCT has a considerable role) and functional (visual field) optic nerve measurements, Both technologies have strengths and limitations.
A new technology for diagnosis and follow-up that can avoid the limitations summarized above is lacking. OCTA seems to be a good candidate for such a role, OCT can detect the Doppler frequency shift of the backscattered light that provides information on blood flow.
- Being tested
- POAG group, Control group
- 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.
POAG groupOther
Patients had intraocular pressure (IOP)>21 mmHg.
Control groupOther
Patients without family history of primary open-angle glaucoma (POAG), IOP ˂21mm Hg.
| Study group | Role | What they receive |
|---|---|---|
| POAG group | Patients had intraocular pressure (IOP)>21 mmHg, Receives: Other: POAG group | |
| Control group | Patients without family history of primary open-angle glaucoma (POAG), IOP ˂21mm Hg. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripapillary vessel density (PpVD)
Peripapillary vessel density (PpVD) was examined with swept-source OCT(DRI OCT Triton;Topcon Corporation,Tokyo,Japan) after pupillary dilatation , using an optic disc scan , peripapillary vessel density was derived from the images acquired with a 6 mm x6 mm mm field of view centered on the optic disc.
PpVD measurements were calculated within the RNFL in a slab from the internal limiting membrane (ILM) to the RNFL posterior boundary.
Measured: 12 months post-procedure
Secondary outcomes (4)
Pattern standard deviation (PSD)
Pattern standard deviation ( PSD) on Visual field test was performed with the Swedish Interactive Threshold Algorithm (SITA) Standard strategy program 24-2 of the octopus polar analysis which measures 24 degrees temporally and 30 degrees nasally and test 54 points.
Measured: 12 months post-procedure
Mean deviation (MD)
Mean deviation(MD) on Visual field test was performed with the Swedish Interactive Threshold Algorithm (SITA) Standard strategy program 24-2 of the octopus polar analysis which measures 24 degrees temporally and 30 degrees nasally and test 54 points.
Measured: 12 months post-procedure
The thickness of the peripapillary retinal nerve fiber layer(RNFL)
The thickness of the peripapillary retinal nerve fiber layer(RNFL) was obtained from a circle with a diameter of 3.4 mm centered on the optic disc.
The RNFL thickness in 4 quadrants and 12 clock-hour were obtained by using the built-in automated segmentation algorism of the system.
Measured: 12 months post-procedure
Intraocular pressure (IOP)
Intraocular pressure (IOP) was recorded.
Measured: 12 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start30 Dec 2021
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual FieldStudies 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
- 100 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miadaa Hassan Hassaneen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978101
- Sponsor's protocol ID
- MD/AZ.AST./OPH026/10/191/1/202
- Status last verified
- May 2025
- First submitted
- 11 May 2025
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Visual Field Changes and OCT Angiographic Chorioretinal Changes in Patients With Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT06978101
- Acronym / sponsor ID
- MD/AZ.AST./OPH026/10/191/1/202
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 18 May 2025 (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.
This study aimed to assess the correlation between visual field changes and optical coherence tomography (OCT) angiography changes of retinal nerve fiber layer in patients with primary open angle glaucoma.
Detailed description
Glaucoma is the leading cause of irreversible blindness worldwide. Since glaucomatous damage is preventable but irreversible, an early diagnosis and close follow-up of glaucoma patients are primordial. Optical coherence tomography angiography (OCTA) is a recently developed, noninvasive imaging modality that detects blood flow through the motion contrast generated by red blood cells.
Currently, there are 2 groups of complementary exams used for the diagnosis and follow-up of glaucoma patients: structural (where OCT has a considerable role) and functional (visual field) optic nerve measurements, Both technologies have strengths and limitations.
A new technology for diagnosis and follow-up that can avoid the limitations summarized above is lacking. OCTA seems to be a good candidate for such a role, OCT can detect the Doppler frequency shift of the backscattered light that provides information on blood flow.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POAG group | – | Other: POAG groupPatients had intraocular pressure (IOP)>21 mmHg, |
| Control group | – | Other: Control groupPatients without family history of primary open-angle glaucoma (POAG), IOP ˂21mm Hg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective cohort nonrandomized trial was carried out on 100 cases with primary open-angle glaucoma (POAG) group (n=80): had intraocular pressure (IOP)>21 mmHg, and control group (n=20): without family history of POAG, IOP ˂21mm Hg.
Key inclusion criteria (1 listed)
- Primary open angle glaucoma patients.
Key exclusion criteria (6 listed)
- Hazy media.
- Diabetic Retinopathy.
- Uveitis.
- Other Glaucomas
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 |
|---|---|---|
| POAG groupPatients had intraocular pressure (IOP)>21 mmHg. | Other | POAG group |
| Control groupPatients without family history of primary open-angle glaucoma (POAG), IOP ˂21mm Hg. | Other | Control group |
Primary outcome
Peripapillary vessel density (PpVD)
Time frame: 12 months post-procedure
Peripapillary vessel density (PpVD) was examined with swept-source OCT(DRI OCT Triton;Topcon Corporation,Tokyo,Japan) after pupillary dilatation , using an optic disc scan , peripapillary vessel density was derived from the images acquired with a 6 mm x6 mm mm field of view centered on the optic disc. PpVD measurements were calculated within the RNFL in a slab from the internal limiting membrane (ILM) to the RNFL posterior boundary.
4 secondary outcomes
Pattern standard deviation (PSD)
Time frame: 12 months post-procedure
Mean deviation (MD)
Time frame: 12 months post-procedure
The thickness of the peripapillary retinal nerve fiber layer(RNFL)
Time frame: 12 months post-procedure
Intraocular pressure (IOP)
Time frame: 12 months post-procedure
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 18 May 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Visual Field and OCT Angiography, run by Assiut 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 1 inclusion and 6 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 18 May 2025. 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?
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?
Peripapillary vessel density (PpVD) (time frame: 12 months post-procedure). 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 18 May 2025.