Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma

Glaucoma Clinical Trial

— OGA  

Official title:

Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06274593
• Other study ID #: AP_JBD_MJ_003
• Status: Not yet recruiting
• Start date: April 2024
• Est. completion date: September 2027

Study information

• Verified date: February 2024
• Source: Nantes University Hospital
• Contact: Jean-Baptiste Ducloyer, M.D
• Phone: 02 40 08 34 01
• Email: jeanbatiste.ducloyer[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2027
• Est. primary completion date: April 2027
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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)

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• OCT
Peripapillary angiography (OCT) at baseline and each year during 3 year

Locations

Country	Name	City	State
France	Jean-Baptiste Ducloyer	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 year
Primary	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.	3 year
Primary	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	3 year
Secondary	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)	3 years