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OCT Angiography in the Glaucoma Diagnosis (OCTA)

Primary Purpose

Glaucoma

Status
Active
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Case Group
Control Group
Sponsored by
Fondation Hôpital Saint-Joseph
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Glaucoma focused on measuring Glaucoma, OCT, OCTA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Groupe Hospitalier Paris Saint-Joseph
  • Polyclinique de la Baie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Case Group

Control Groupe

Arm Description

The "Case" group corresponds to patients with glaucoma following the clinical criteria for glaucoma: papilla excavation> 5/10 with altered ISNT rule, or neuro-retinal rhyme characteristic of glaucoma, or fiber alterations characteristic of glaucoma. OCT with typical alterations (loss of the layer of nerve fibers or loss of these ganglion cells), loss of fibers typical of glaucoma. Humphrey 24: 2 visual fields produced, reliable and typical of glaucoma. The assignment to the "Cas" group will be carried out by an ophthalmologist specializing in glaucoma according to the following criteria: - The intraocular pressure must be increased before the start of treatment (21 mmHg or more), except in cases of normal pressure glaucoma. The additional examination corresponds to an OCTA alone leading to an extension of the duration of the consultation by 5 minutes.

The Control group corresponds to patients with no glaucoma, no suspicion or history of glaucoma, ocular hypertension, or alterations detected during the ophthalmological consultation. Witnesses will be matched to cases by age (+/- 5 years) and gender. For patients in this group, the additional examinations correspond to a visual field, an OCT and an OCTA leading to an extension of the duration of the consultation by 35 minutes.

Outcomes

Primary Outcome Measures

Vascular density between the 2 groups
This outcome corresponds to percentage of vascularization of the optic papilla measured using OCTA.

Secondary Outcome Measures

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.
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).
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.
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.

Full Information

First Posted
June 16, 2020
Last Updated
April 26, 2023
Sponsor
Fondation Hôpital Saint-Joseph
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1. Study Identification

Unique Protocol Identification Number
NCT04437446
Brief Title
OCT Angiography in the Glaucoma Diagnosis
Acronym
OCTA
Official Title
OCT Angiography in the Glaucoma Diagnosis : A Multicenter Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 21, 2020 (Actual)
Primary Completion Date
January 21, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Hôpital Saint-Joseph

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, OCT, OCTA

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study is a prospective multicentric and interventional trial that aims to compare the vascular density between patients with glaucoma and patients without glaucoma.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Case Group
Arm Type
Experimental
Arm Description
The "Case" group corresponds to patients with glaucoma following the clinical criteria for glaucoma: papilla excavation> 5/10 with altered ISNT rule, or neuro-retinal rhyme characteristic of glaucoma, or fiber alterations characteristic of glaucoma. OCT with typical alterations (loss of the layer of nerve fibers or loss of these ganglion cells), loss of fibers typical of glaucoma. Humphrey 24: 2 visual fields produced, reliable and typical of glaucoma. The assignment to the "Cas" group will be carried out by an ophthalmologist specializing in glaucoma according to the following criteria: - The intraocular pressure must be increased before the start of treatment (21 mmHg or more), except in cases of normal pressure glaucoma. The additional examination corresponds to an OCTA alone leading to an extension of the duration of the consultation by 5 minutes.
Arm Title
Control Groupe
Arm Type
Experimental
Arm Description
The Control group corresponds to patients with no glaucoma, no suspicion or history of glaucoma, ocular hypertension, or alterations detected during the ophthalmological consultation. Witnesses will be matched to cases by age (+/- 5 years) and gender. For patients in this group, the additional examinations correspond to a visual field, an OCT and an OCTA leading to an extension of the duration of the consultation by 35 minutes.
Intervention Type
Diagnostic Test
Intervention Name(s)
Case Group
Intervention Description
The additional examination corresponds to an OCTA which is a non-invasive examination, without potential risks, without radiation, using infrared light.
Intervention Type
Diagnostic Test
Intervention Name(s)
Control Group
Intervention Description
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
Primary Outcome Measure Information:
Title
Vascular density between the 2 groups
Description
This outcome corresponds to percentage of vascularization of the optic papilla measured using OCTA.
Time Frame
Day1
Secondary Outcome Measure Information:
Title
Papilla supply according to severity of glaucoma
Description
This outcome corresponds to the comparison of the percentages of vascular density as a function of the severity of glaucoma.
Time Frame
Day 1
Title
Difference of papilla vascularization depending on the regions of the papilla
Description
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).
Time Frame
Day 1
Title
Vascularization of different regions of the papilla between case patients and control patients
Description
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.
Time Frame
Day 1
Title
Evaluation of the diagnostic performance of OCTA
Description
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.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yves LACHKAR, MD
Organizational Affiliation
Fondation Hôpital Saint-Joseph
Official's Role
Study Director
Facility Information:
Facility Name
Groupe Hospitalier Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Polyclinique de la Baie
City
Saint-Martin-des-Champs
ZIP/Postal Code
50300
Country
France

12. IPD Sharing Statement

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OCT Angiography in the Glaucoma Diagnosis

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