OCT Angiography in the Glaucoma Diagnosis

NCT04437446 | Unknown

• 1 other identifier: OCTA
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 2

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.

Conditions

Glaucoma

Keywords

Glaucoma; OCT; OCTA

Outcome Measures

Primary Outcomes (1)

• Vascular density between the 2 groups

  This outcome corresponds to percentage of vascularization of the optic papilla measured using OCTA.

  Day1

Secondary Outcomes (4)

• Papilla supply according to severity of glaucoma

  Day 1

• Difference of papilla vascularization depending on the regions of the papilla

  Day 1

• Vascularization of different regions of the papilla between case patients and control patients

  Day 1

• Evaluation of the diagnostic performance of OCTA

  Day 1

Study Arms (2)

Case Group

EXPERIMENTAL

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.

Diagnostic Test: Case Group

Control Groupe

EXPERIMENTAL

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.

Diagnostic Test: Control Group

Interventions

Case Group DIAGNOSTIC_TEST

The additional examination corresponds to an OCTA which is a non-invasive examination, without potential risks, without radiation, using infrared light.

Case Group

Control Group DIAGNOSTIC_TEST

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

Control Groupe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (2)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Polyclinique de la Baie

Saint-Martin-des-Champs, 50300, France

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Yves LACHKAR, MD

  Fondation Hôpital Saint-Joseph

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is a prospective multicentric and interventional trial that aims to compare the vascular density between patients with glaucoma and patients without glaucoma.

Study Record Dates

• First Submitted: June 16, 2020
• First Posted: June 18, 2020
• Study Start: July 21, 2020
• Primary Completion: January 21, 2022
• Study Completion: December 31, 2023
• Last Updated: April 27, 2023

Record last verified: 2023-04

Locations

FR (2)