NCT02178085

Brief Summary

Background : Glaucoma is a common disease, potentially blinding, characterized by progressive damage to the optic nerve. If the intraocular pressure is the most known risk factor, however, there are cases of glaucoma scalable despite well-controlled intraocular pressure, ocular hypertension without glaucoma or glaucoma without ocular hypertension (normal tension glaucoma). Purpose :Involvement of vascular factors in the development of glaucoma and scalability has been proved, associated with a possible loss of vascular autoregulation. The objective of this study is to quantify MRI flow of blood flows referred ophthalmic patients with glaucoma untreated comparison with control subjects.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 30, 2014

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

4.5 years

First QC Date

June 18, 2014

Last Update Submit

August 9, 2018

Conditions

Glaucoma

Keywords

glaucomaphase-contrast MRIblood flowcerebrospinal fluid

Outcome Measures

Primary Outcomes (1)

  • Arterial blood flow

    Measure of the mean arterial blood flow during the cardiac cycle in the ophthalmic artery.

    Day 1

Secondary Outcomes (3)

  • Vascular flow curves

    Day 1

  • Cerebrospinal fluid (CSF) dynamic

    Day 1

  • Treatment response

    Day 180

Study Arms (1)

Flow imaging

EXPERIMENTAL

Glaucoma patients and healthy subjects who will undergo ocular flow imaging

Other: Flow imaging

Interventions

Flow imagingOTHER

Participants will undergo morphological and then flow MRI. Flow MR images will be processed adequately to obtain quantitative values of arterial and venous flow as well as CSF flow.

Also known as: Flow MRI, Cine phase-constrast magnetic resonance imaging, Cerebral blood flow
Flow imaging

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult participants
  • Diagnosis of primary open angle glaucoma or normal-tension glaucoma
  • Never received any anti glaucoma therapy
  • Patients included in the group " normal pressure glaucoma " are patients where the diagnosis of optic neuropathy have been worn by the ophthalmologist with measured intraocular pressure \<21 mmHg.

You may not qualify if:

  • Anyone with a classic contraindication to MRI
  • Cardiovascular comorbidities or neurovascular : uncontrolled systemic hypertension , Diabetes, heart failure , carotid stenosis , ischemic stroke or transient ischemic attack.
  • Already treated glaucoma
  • Prescription by the ophthalmologist another treatment than prostaglandin analogue treatment.
  • Other clinical forms of glaucoma : angle closure glaucoma, neovascular glaucoma, exfoliative glaucoma, secondary glaucomas, pigment dispersion glaucoma, traumatic glaucoma, congenital glaucoma
  • History of intraocular or orbital surgery of less than 6 months .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Amiens

Amiens, Picardie, 80054, France

RECRUITING

Centre d'ophtalmologie Victor Pauchet

Amiens, Picardie, 80090, France

NOT YET RECRUITING

MeSH Terms

Conditions

Glaucoma

Interventions

Cerebrovascular Circulation

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Intervention Hierarchy (Ancestors)

Blood CirculationCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Olivier Balédent, PhD

    CHU Amiens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivier Balédent, PhD

CONTACT

+33 3 22 66 86 73olivier.baledent@chu-amiens.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 30, 2014

Study Start

March 1, 2015

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

FR(2)