Open Angle GlaucomaNCT05104294
Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Glaucoma
An observational study of Open Angle Glaucoma, run by Benha University at 1 site in Egypt.
Trial summary
Open angle glaucoma (OAG) is considered a common cause of irreversible vision loss worldwide. It is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (RGC) and its axons (retinal nerve fiber layer; RNFL), which lead to neuroretinal rim excavation and corresponding… Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- Optical Coherence Tomography- Angiography and Photopic negative response
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2020to 15 Aug 2020
- 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: One hundreds fifty-two eyes of 76 participants were included in this study, with the participants recruited from the outpatient glaucoma clinic of Benha University Hospital, EGYPT.
Who may be able to join
- Age of 30 years or older for both control and glaucoma groups.
- Spherical equivalent (SE) between -2 and +2 D.
- No history of previous eye surgery, trauma, or systemic diseases.
Who cannot join
- Spherical equivalent greater than +/- 2.00 diopters (D).
- Media opacity as (cataract or corneal scar).
- Any history of ocular surgeries or trauma.
- Optic nerve anomaly or other retinal diseases.
- Unreliable visual field tests (33% fixation losses, false positive, and false- negative results).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Primary Open Angle Glaucoma
Open angle glaucoma (OAG) is considered a common cause of irreversible vision loss worldwide. It is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (RGC) and its axons (retinal nerve fiber layer; RNFL), which lead to neuroretinal rim excavation and corresponding visual field defects.
Read the detailed description
Open angle glaucoma (OAG) is considered a common cause of irreversible vision loss worldwide. It is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (RGC) and its axons (retinal nerve fiber layer; RNFL), which lead to neuroretinal rim excavation and corresponding visual field defects.
OCT Angiography (OCTA) is a promising tool for diagnosing and monitoring glaucomatous patients. It can evaluate glaucomatous damage and assess the ganglion cells' health by measuring blood flow within the optic nerve and the retina Correlation between vascular , structural and functional changes of the peripapillary retinal nerve fiber (RNFL) and macular/ganglion cell complex (GCC) can lead to early detection of glaucomatous changes.
- Conditions
- Open Angle Glaucoma
- Being tested
- Optical Coherence Tomography- Angiography, Photopic negative response
- Keywords
- Open angle glaucoma, Optical coherence Tomography, Photopic negative response
- 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.
Optical Coherence Tomography- AngiographyDiagnostic test
Also called OCT-A
Peripapillary retinal nerve fiber layer thickness, ganglion cell complex, superficial and deep capillary plexus vessel density were measured.
Photopic negative responseDiagnostic test
Also called PhNR
Both the implicit time and amplitude of PhNR were recorded.
| Study group | Role | What they receive |
|---|---|---|
| mild Primary Open Angle Glaucoma group (Group I) | 28 eyes of 16 patients with mild primary open angle glaucoma as group I. Receives: Diagnostic Test: Optical Coherence Tomography- Angiography; Diagnostic Test: Photopic negative response | |
| moderate to severe Primary Open Angle Glaucoma group (Group II) | 44 eyes of 24 patients with moderate to severe primary open angle glaucoma as group II. Receives: Diagnostic Test: Optical Coherence Tomography- Angiography; Diagnostic Test: Photopic negative response | |
| Control Group | 80 eyes of 40 healthy subjects as control group. Receives: Diagnostic Test: Optical Coherence Tomography- Angiography; Diagnostic Test: Photopic negative response |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between vascular, structural and functional changes of the peripapillary retinal nerve fiber and macular ganglion cell complex in patients with open angle glaucoma.
Correlation between RNFL thickness and GCC measured by OCT-A with implicit time and amplitude of Photopic Negative Response (PhNR) measured by electroretinogram.
Measured: Immediately after OCTA and electroretinogram diagnostic tests for each eye.
Secondary outcomes (1)
Assess the validity of OCTA parameters and PhNR in early detection of glaucoma changes.
Changes in the parameters were measured by OCT-A as Superficial and deep vessel Density.
Measured: Immediately after OCTA and electroretinogram diagnostic tests for each eye.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start2 Feb 2020
- Primary completion14 Jul 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Angle GlaucomaStudies 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
- Cross-sectional
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Marwa A Tabl, MD, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104294
- Sponsor's protocol ID
- RC-9-11-01
- Status last verified
- Oct 2021
- First submitted
- 20 Oct 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tabl AA, Tabl MA. Correlation between OCT-angiography and photopic negative response in patients with primary open angle glaucoma. Int Ophthalmol. 2023 Jun;43(6):1889-1901. doi: 10.1007/s10792-022-02588-9. Epub 2022 Nov 28.
PubMed 36441346
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Optical Coherence Tomography Angiography and Photopic Negative Response in Patients With Primary Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT05104294
- Acronym / sponsor ID
- RC-9-11-01
- Conditions
- Open Angle Glaucoma
- Keywords
- Open angle glaucoma, Optical coherence Tomography, Photopic negative response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 2 Feb 2020 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 2 Nov 2021 (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.
Open angle glaucoma (OAG) is considered a common cause of irreversible vision loss worldwide. It is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (RGC) and its axons (retinal nerve fiber layer; RNFL), which lead to neuroretinal rim excavation and corresponding visual field defects.
Detailed description
Open angle glaucoma (OAG) is considered a common cause of irreversible vision loss worldwide. It is an optic neuropathy associated with progressive loss and degeneration of the retinal ganglion cell layer (RGC) and its axons (retinal nerve fiber layer; RNFL), which lead to neuroretinal rim excavation and corresponding visual field defects.
OCT Angiography (OCTA) is a promising tool for diagnosing and monitoring glaucomatous patients. It can evaluate glaucomatous damage and assess the ganglion cells' health by measuring blood flow within the optic nerve and the retina Correlation between vascular , structural and functional changes of the peripapillary retinal nerve fiber (RNFL) and macular/ganglion cell complex (GCC) can lead to early detection of glaucomatous changes.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mild Primary Open Angle Glaucoma group (Group I) | – | Diagnostic Test: Optical Coherence Tomography- Angiography, Diagnostic Test: Photopic negative response28 eyes of 16 patients with mild primary open angle glaucoma as group I. |
| moderate to severe Primary Open Angle Glaucoma group (Group II) | – | Diagnostic Test: Optical Coherence Tomography- Angiography, Diagnostic Test: Photopic negative response44 eyes of 24 patients with moderate to severe primary open angle glaucoma as group II. |
| Control Group | – | Diagnostic Test: Optical Coherence Tomography- Angiography, Diagnostic Test: Photopic negative response80 eyes of 40 healthy subjects as control group. |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- One hundreds fifty-two eyes of 76 participants were included in this study, with the participants recruited from the outpatient glaucoma clinic of Benha University Hospital, EGYPT.
Key inclusion criteria (3 listed)
- Age of 30 years or older for both control and glaucoma groups.
- Spherical equivalent (SE) between -2 and +2 D.
- No history of previous eye surgery, trauma, or systemic diseases.
Key exclusion criteria (5 listed)
- Spherical equivalent greater than +/- 2.00 diopters (D).
- Media opacity as (cataract or corneal scar).
- Any history of ocular surgeries or trauma.
- Optic nerve anomaly or other retinal diseases.
- Unreliable visual field tests (33% fixation losses, false positive, and false- negative results).
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- AngiographyAlso: OCT-APeripapillary retinal nerve fiber layer thickness, ganglion cell complex, superficial and deep capillary plexus vessel density were measured. | Diagnostic test | Control Group, mild Primary Open Angle Glaucoma group (Group I), moderate to severe Primary Open Angle Glaucoma group (Group II) |
| Photopic negative responseAlso: PhNRBoth the implicit time and amplitude of PhNR were recorded. | Diagnostic test | Control Group, mild Primary Open Angle Glaucoma group (Group I), moderate to severe Primary Open Angle Glaucoma group (Group II) |
Primary outcome
Correlation between vascular, structural and functional changes of the peripapillary retinal nerve fiber and macular ganglion cell complex in patients with open angle glaucoma.
Time frame: Immediately after OCTA and electroretinogram diagnostic tests for each eye.
Correlation between RNFL thickness and GCC measured by OCT-A with implicit time and amplitude of Photopic Negative Response (PhNR) measured by electroretinogram.
1 secondary outcome
Assess the validity of OCTA parameters and PhNR in early detection of glaucoma changes.
Time frame: Immediately after OCTA and electroretinogram diagnostic tests for each eye.
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 2 Nov 2021.
- Derived from this study: PubMed 36441346Tabl AA, Tabl MA. Correlation between OCT-angiography and photopic negative response in patients with primary open angle glaucoma. Int Ophthalmol. 2023 Jun;43(6):1889-1901. doi: 10.1007/s10792-022-02588-9. Epub 2022 Nov 28.
- Individual participant dataSharing planned: No
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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.
Marwa A Tabl, MD study chair
Benha 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 Open Angle Glaucoma, run by Benha 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 3 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: finished, as of the sponsor's last update on 2 Nov 2021. 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?
Correlation between vascular, structural and functional changes of the peripapillary retinal nerve fiber and macular ganglion cell complex in patients with open angle glaucoma. (time frame: Immediately after OCTA and electroretinogram diagnostic tests for each eye.). 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 NCT05104294, which also lists 1 linked publication.
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 2 Nov 2021.