OCT Angiography in the Glaucoma Diagnosis

Glaucoma Clinical Trial

— OCTA  

Official title:

OCT Angiography in the Glaucoma Diagnosis : A Multicenter Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04437446
• Other study ID #: OCTA
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 21, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Glaucoma is a chronic degenerative disease of the optic nerve. It is the second cause of blindness worldwide and a frequent cause of irreversible blindness. In 2020, epidemic health authorities have predicted about 80 million glaucoma patients. Glaucoma can be treated by topical treatment (eye drops), laser or surgery. A premature diagnosis of glaucoma is very important to prevent irreversible blindness. Pachymetry, Optical Coherence Tomography (OCT) and visual fields exams are fundamental for the development of the glaucoma diagnosis. The severity of glaucoma is defined with Hodapp-Parrish-Andersen visual field criteria. According to these criteria, glaucoma can be classified as early (with average visual field deviation, MD, of 0 to -6 dB), moderate (MD of -6 to -12 dB) and severe (MD worse than -12 dB). The progression of glaucoma is being identified by the visual fields tests, and also by the progression of alterations in the optic nerve head. The visual fields tests are long and difficult (30 minutes). It is therefore important to create additional tests and anticipate the diagnosis, in order to avoid the irreversibility of glaucoma.

Description:

The OCT Angiography (OCTA) is a non-invasive technology, marketed since 2014, that uses OCT with infrared light, with no radiation nor side effects, to evaluate within seconds the vascularization of the fundus, retina and optic nerve head, which may be useful for the glaucoma diagnosis. A recent meta-analysis has shown a decrease of the vascular density (DV) in glaucoma, so that OCTA may be useful in the advanced diagnosis of glaucoma. However, the VD values obtained were different depending on the device. In addition, no studies with the OCT Triton (Topcon®) device were considered in the analysis. The authors suggested the development of dedicated software, which would allow the evaluation of VD with different devices for a more independent and valid assessment. On the other hand, recent studies show that the diagnostic capacity of OCTA may be superior to that of OCT, and that OCTA may be more useful in determining the severity of glaucoma than OCT. It is therefore necessary to evaluate the additional diagnostic tests whether they are non-invasive and whether it allow us to give a faster diagnosis.

This study is aimed at comparing the diagnostic utility of OCTA with standard complementary glaucoma examinations (OCT and CV).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 91
• Est. completion date: December 31, 2023
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient whose age = 18 years

• Patient consultant in the ophthalmology department of the Marie-Thérèse Health Center or the Polyclinique de la Baie

• French speaking patient

• Patient affiliated to a health insurance plan

• Patient having given free, informed and express consent

Exclusion Criteria:

• Patient with another ophthalmological pathology or a history of ophthalmological pathology

• Patient with a history of ophthalmic surgery except for uncomplicated cataract surgery

• Patient under guardianship or curatorship

• Patient deprived of liberty

• Pregnant or lactating woman

Related Conditions & MeSH terms

• Glaucoma

Intervention

Diagnostic Test:
• Case Group
The additional examination corresponds to an OCTA which is a non-invasive examination, without potential risks, without radiation, using infrared light.
• Control Group
The additional examinations correspond to: OCTA which is a non-invasive examination, without potential risks, without radiation, using infrared light. OCT: non-invasive examination, without potential risks, without radiation, using infrared light. The patient must sit in front of a screen and a contact is taken without contact in about ten seconds. Visual field

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris
France	Polyclinique de la Baie	Saint-Martin-des-Champs

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vascular density between the 2 groups	This outcome corresponds to percentage of vascularization of the optic papilla measured using OCTA.	Day1
Secondary	Papilla supply according to severity of glaucoma	This outcome corresponds to the comparison of the percentages of vascular density as a function of the severity of glaucoma.	Day 1
Secondary	Difference of papilla vascularization depending on the regions of the papilla	This outcome corresponds to the comparison of the percentages of vascular density as a function of the regions of the papilla (intra-papillary, peripapillary, superior, inferior, nasal, temporal).; 184/5000 corresponds to the comparison of the percentages of vascular density as a function of the regions of the papilla (intra-papillary, peripapillary, superior, inferior, nasal, temporal).	Day 1
Secondary	Vascularization of different regions of the papilla between case patients and control patients	This outcome corresponds to the comparison of the percentages of vascular density of the regions of the papilla between the case patients and the control patients.	Day 1
Secondary	Evaluation of the diagnostic performance of OCTA	This outcome corresponds to the comparison of the sensitivity and the specificity of OCTA compared to the additional examinations conventionally carried out within the framework of the diagnosis of glaucoma (OCT and visual fields) within the various regions of the vascular papilla between the case patients and the control patients.	Day 1