Clinical Investigation on the Blood Oxygenation at the Optic Nerve Head in Fabry Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02023086
• Date of registration: 10/12/2013
• Prospective Registration: Yes
• Primary sponsor: Université de Montréal
• Public title: Clinical Investigation on the Blood Oxygenation at the Optic Nerve Head in Fabry Patients
• Scientific title: Clinical Investigation on the Blood Oxygenation at the Optic Nerve Head in Relation With Visual Field Loss in Fabry Patients
• Date of first enrolment: August 2014
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02023086
• Study type: Observational [Patient Registry]
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Langis Michaud, OD M.Sc.
• Affiliation: Universite de Montreal

Key inclusion & exclusion criteria

Inclusion Criteria:

Inclusion criteria (Fabry group):

- Aged over 18 years old

- Being diagnosed with Fabry disease

- 3 subjects will be under enzyme replacement treatment for the treatment of Fabry
disease.

- 3 subjects will not receive enzyme replacement treatment

- Is fit to give legal consent.

- Is available for a period of 2 years

Inclusion criteria (CONTROL group):

- Matched for age and sex with group A - 6 participants

- Being healthy, with no known chronic systemic disease nor acute disease at the moment
of the recruitment

- Is fit to give legal consent.

- Is available for a period of 2 years

Exclusion Criteria:( both groups):

- Presents with an active pathological ocular condition

- Presence of an abnormal optic nerve (congenital or acquired)

- Usage of topical ocular drug(s) at the time of selection

- To have known allergy to topical diagnostic drugs used in this study

- Usage of systemic medication with known effect on the visual field



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Fabry Disease

Intervention(s)

Drug: Tropicamide

Procedure: Slit Lamp assessment and intra-ocular pressure measurement

Procedure: Contrast sensitivity measurement

Procedure: Visual field testing

Device: OSOME

Procedure: Oxygen flow at the optic nerve head measurement

Primary Outcome(s)

Blood oxygenation at the optic nerve head [Time Frame: up to 2 years]

Secondary Outcome(s)

Origin of visual field defect in Fabry patients [Time Frame: up to 2 years]

Secondary ID(s)

GZ-2012-10918

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Genzyme, a Sanofi Company