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

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to evaluate blood oxygenation at the optic nerve head in relation with visual field losses observed in many Fabry patients. Data collected will allow to evaluate if there is a link between these two entities.

Study will last up to 2 years during which a limited number of Fabry patients will be compared to a control group to confirm any relationship between blood flow and field losses, and to see if these results vary over time.

HYPOTHESIS

1. Fabry patients will present significant differences in visual fields compared to control 2 There will be variability of the visual field defects on the long term but not on the short term 3 Blood oxygenation will be higher for Fabry patients 4 Blood volume at the optic nerve head will be the same for both groups.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Université de Montréal
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Mydriatics; Tropicamide

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