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

Université de Montréal

Status: Completed

Conditions: Fabry Disease

Treatments: Procedure: Visual field testing; Device: OSOME; Procedure: Oxygen flow at the optic nerve head measurement; Procedure: Contrast sensitivity measurement; Procedure: Slit Lamp assessment and intra-ocular pressure measurement; Drug: Tropicamide

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02023086

GZ-2012-10918

Details and patient eligibility

About

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

Study lasted 2 years during which a limited number of Fabry patients had been compared to a control group to confirm any relationship between blood flow and field losses, and to see if these results varied 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.

Full description

The first subjects who meet the following criteria will be enrolled in the study.

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

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and 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

Trial design

8 participants in 2 patient groups

FABRY group

Description:

* contrast sensitivity measurement * slit lamp assessment and intra-ocular pressure measurement * ocular coherence tomography at the optic nerve head * visual field testing * OSOME (oxygen flow at the optic nerve head measurement) * Tropicamide

Treatment:

Drug: Tropicamide

Procedure: Slit Lamp assessment and intra-ocular pressure measurement

Procedure: Contrast sensitivity measurement

Procedure: Oxygen flow at the optic nerve head measurement

Device: OSOME

Procedure: Visual field testing

CONTROL group (Historical database)

Description:

* contrast sensitivity measurement * slit lamp assessment and intra-ocular pressure measurement * ocular coherence tomography at the optic nerve head * visual field testing * oxygen flow at the optic nerve head measurement (OSOME) * Under tropicamide

Treatment:

Drug: Tropicamide

Procedure: Slit Lamp assessment and intra-ocular pressure measurement

Procedure: Contrast sensitivity measurement

Procedure: Oxygen flow at the optic nerve head measurement

Device: OSOME

Procedure: Visual field testing