GlaucomaOGANCT06274593
Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma
An observational study of Glaucoma, run by Nantes University Hospital at 2 sites in France.
Trial summary
Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- OCT
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 2 sitesFrance
- Study dates
- 27 Apr 2024to Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Patients followed at Nantes University Hospital for advanced glaucoma (MD>10dB in visual field) who had peripapillary angiography OCT, OCTrnfl and visual field at their follow-up consultation.
Who may be able to join
- Men and women aged 18 and over
- Patient with glaucoma followed in the ophthalmology department of Nantes University Hospital
- mean visual field deficit (MD) >10dB
Who cannot join
- Retinal vascular pathology (moderate to severe non-proliferative diabetic retinopathy, complicated diabetic retinopathy, OVCR/OBVR, OACR/OBAR, NOIAA...) Non-glaucomatous optic neuropathy, neurological pathology leading to visual field deficit (stroke with HLH, quadranopsia, chiasmatic Sd...)
- PPR (retinal PanPhotocoagulation), retinal cerclage
- Retinal pathology leading to visual field impairment (e.g. retinitis pigmentosa)
- AMD and other macular pathologies that can lead to central visual field deficits
- Significant environmental disorders impairing retinal imaging (e.g. active uveitis, dense cataract)
- Loss of fixation point preventing visual field formation Pregnant or breast-feeding women
Show all 9Show fewer
- Protected adults under guardianship or curatorship
- with unreliable visual fields (false positives and false negatives > 33%)
- with an uninterpretable OCTrnfl or OCTa (artifact, low quality score)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Nantes
Nantes, Nantes, 44000
Ducloyer, MD; PhD, alexandra.poinas@chu-nantes.fr
- Not yet recruiting
Jean-Baptiste Ducloyer
Nantes, Nantes, 44093
Jean-Baptiste Ducloyer, MD, jeanbaptiste.ducloyer@chu-nantes.fr
About this study
Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.
To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma.
The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).
Read the detailed description
Glaucoma is a chronic disease of the optic nerve characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second-leading cause of blindness after cataracts and the leading cause of irreversible blindness.
The pathophysiology and loss of retinal ganglion cells are partly explained by 2 main theories:
- biomechanical theory, which takes into account the forces and deformations of the optic nerve linked to IOP (intraocular pressure) and to the anatomy of the optic nerve head, particularly at the level of the cribriform plate (a zone of deformable weakness surrounded by a rigid scleral shell),
- the vascular theory, explained by abnormalities in the vascularization of the optic nerve and retina.
Optical coherence tomography angiography (OCTa) is a relatively new imaging method that has been on the market for around ten years.
It is a non-invasive method that provides qualitative and quantitative information on retinal vascularization and the optic nerve head. The movement of red blood cells is used as a contrast medium to differentiate blood vessels from static tissue.
In glaucoma, changes in the peripapillary vascular plexus (around the optic nerve head) can be observed and are topographically correlated with visual field and peripapillary nerve fiber deficits.
One of the challenges in monitoring glaucoma patients lies in detecting the progression of the disease with the help of various complementary examinations, including the visual field, peripapillary nerve fiber OCT (RNFL), and more recently, OCTa.
The visual field is used to detect areas of vision deficit (peripheral or sometimes central), known as scotomas, and to monitor their evolution. RNFL OCT measures the thickness of the optic nerve (in micrometers) in its various quadrants. OCTa measures vascular density, also by quadrant, around the optic nerve head.
A deterioration in any of these parameters can help guide therapeutic management by modifying medical treatment or proposing surgery to lower intraocular pressure in the affected eye.
One of the difficulties in monitoring glaucoma patients lies in detecting optic nerve thinning in patients with advanced optic nerve damage. It is now well known that at an advanced stage of the disease, measurement of optic nerve thickness on RNFL OCT can reach a "floor" effect: residual non-neuronal tissue limits the usefulness of detecting changes in neuronal tissue, and disease progression can only be detected by visual field monitoring.
Vascular density measured on OCTa appears to reach a plateau effect in a delayed manner compared with measurements obtained on peripapillary OCT (RNFL) and could enable better monitoring of disease progression in patients with advanced glaucoma.
Indeed, a new objective follow-up criterion measured with OCTa in clinical practice for patients with uninterpretable OCTrnfl would be a valuable tool for assessing the rate of glaucoma progression in these patients and thus defining the rate of monitoring and the decision to intensify treatment in the event of progression. This is all the more important as the treatments available for glaucoma are sometimes invasive (drainage devices, surgery, etc.). Assessing the benefit-risk balance therefore requires objective data for these patients.
To date, to our knowledge, there are no studies analyzing the evolution of OCT angiography in glaucoma patients.
The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).
- Conditions
- Glaucoma
- Being tested
- OCT
- Keywords
- glaucoma, OCTa, OCTrnfl
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDevice
Peripapillary angiography (OCT) at baseline and each year during 3 year
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the progression of vascular density (VD) in advanced glaucoma patients.
Progression of peripapillary vascular density (VD) (in percent) per sector (8 sectors) with 3-year follow-up.
Measured: 3 year
Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients.
Progression of peripapillary nerve fiber thickness (RNFL, in µm) per sector (8 sectors) with 3-year follow-up.
Measured: 3 year
Compare the progression of visual field in advanced glaucoma patients.
Progression of visual field deficit (in dB) by sector (8 sectors) with 3-year follow-up
Measured: 3 year
Secondary outcomes (1)
CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up
Study of the correlation between CV-OCTrnfl and correlation between CV-OCTa (mean in µm)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2024
- Study start27 Apr 2024
- Primary completion27 Apr 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06274593
- Sponsor's protocol ID
- AP_JBD_MJ_003
- Acronym
- OGA
- Status last verified
- Jun 2026
- First submitted
- 14 Feb 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma
- ClinicalTrials.gov ID
- NCT06274593
- Acronym / sponsor ID
- OGA / AP_JBD_MJ_003
- Conditions
- Glaucoma
- Keywords
- glaucoma, OCTa, OCTrnfl
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 27 Apr 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Feb 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.
Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.
To date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma.
The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).
Detailed description
Glaucoma is a chronic disease of the optic nerve characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second-leading cause of blindness after cataracts and the leading cause of irreversible blindness.
The pathophysiology and loss of retinal ganglion cells are partly explained by 2 main theories:
- biomechanical theory, which takes into account the forces and deformations of the optic nerve linked to IOP (intraocular pressure) and to the anatomy of the optic nerve head, particularly at the level of the cribriform plate (a zone of deformable weakness surrounded by a rigid scleral shell),
- the vascular theory, explained by abnormalities in the vascularization of the optic nerve and retina.
Optical coherence tomography angiography (OCTa) is a relatively new imaging method that has been on the market for around ten years.
It is a non-invasive method that provides qualitative and quantitative information on retinal vascularization and the optic nerve head. The movement of red blood cells is used as a contrast medium to differentiate blood vessels from static tissue.
In glaucoma, changes in the peripapillary vascular plexus (around the optic nerve head) can be observed and are topographically correlated with visual field and peripapillary nerve fiber deficits.
One of the challenges in monitoring glaucoma patients lies in detecting the progression of the disease with the help of various complementary examinations, including the visual field, peripapillary nerve fiber OCT (RNFL), and more recently, OCTa.
The visual field is used to detect areas of vision deficit (peripheral or sometimes central), known as scotomas, and to monitor their evolution. RNFL OCT measures the thickness of the optic nerve (in micrometers) in its various quadrants. OCTa measures vascular density, also by quadrant, around the optic nerve head.
A deterioration in any of these parameters can help guide therapeutic management by modifying medical treatment or proposing surgery to lower intraocular pressure in the affected eye.
One of the difficulties in monitoring glaucoma patients lies in detecting optic nerve thinning in patients with advanced optic nerve damage. It is now well known that at an advanced stage of the disease, measurement of optic nerve thickness on RNFL OCT can reach a "floor" effect: residual non-neuronal tissue limits the usefulness of detecting changes in neuronal tissue, and disease progression can only be detected by visual field monitoring.
Vascular density measured on OCTa appears to reach a plateau effect in a delayed manner compared with measurements obtained on peripapillary OCT (RNFL) and could enable better monitoring of disease progression in patients with advanced glaucoma.
Indeed, a new objective follow-up criterion measured with OCTa in clinical practice for patients with uninterpretable OCTrnfl would be a valuable tool for assessing the rate of glaucoma progression in these patients and thus defining the rate of monitoring and the decision to intensify treatment in the event of progression. This is all the more important as the treatments available for glaucoma are sometimes invasive (drainage devices, surgery, etc.). Assessing the benefit-risk balance therefore requires objective data for these patients.
To date, to our knowledge, there are no studies analyzing the evolution of OCT angiography in glaucoma patients.
The main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients followed at Nantes University Hospital for advanced glaucoma (MD>10dB in visual field) who had peripapillary angiography OCT, OCTrnfl and visual field at their follow-up consultation.
Key inclusion criteria (3 listed)
- Men and women aged 18 and over
- Patient with glaucoma followed in the ophthalmology department of Nantes University Hospital
- mean visual field deficit (MD) >10dB
Key exclusion criteria (9 listed)
- Retinal vascular pathology (moderate to severe non-proliferative diabetic retinopathy, complicated diabetic retinopathy, OVCR/OBVR, OACR/OBAR, NOIAA...) Non-glaucomatous optic neuropathy, neurological pathology leading to visual field deficit (stroke with HLH, quadranopsia, chiasmatic Sd...)
- PPR (retinal PanPhotocoagulation), retinal cerclage
- Retinal pathology leading to visual field impairment (e.g. retinitis pigmentosa)
- AMD and other macular pathologies that can lead to central visual field deficits
- Significant environmental disorders impairing retinal imaging (e.g. active uveitis, dense cataract)
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 |
|---|---|---|
| OCTPeripapillary angiography (OCT) at baseline and each year during 3 year | Device | – |
Primary outcome
Compare the progression of vascular density (VD) in advanced glaucoma patients.
Time frame: 3 year
Progression of peripapillary vascular density (VD) (in percent) per sector (8 sectors) with 3-year follow-up.
Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients.
Time frame: 3 year
Progression of peripapillary nerve fiber thickness (RNFL, in µm) per sector (8 sectors) with 3-year follow-up.
Compare the progression of visual field in advanced glaucoma patients.
Time frame: 3 year
Progression of visual field deficit (in dB) by sector (8 sectors) with 3-year follow-up
1 secondary outcome
CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Nantes University Hospital at 2 sites in France.
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 9 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Baptiste Ducloyer, M.D (02 40 08 34 01, jeanbatiste.ducloyer@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the progression of vascular density (VD) in advanced glaucoma patients. (time frame: 3 year). The study lists 3 primary outcomes in all. 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 24 Jun 2026.