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

Information source: Université de Montréal
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fabry Disease

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

Phase: N/A

Status: Active, not recruiting

Sponsored by: Université de Montréal

Official(s) and/or principal investigator(s):
Langis Michaud, OD M.Sc., Principal Investigator, Affiliation: Universite de Montreal

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.

Clinical Details

Official title: Clinical Investigation on the Blood Oxygenation at the Optic Nerve Head in Relation With Visual Field Loss in Fabry Patients

Study design: Observational Model: Case Control, Time Perspective: Prospective

Primary outcome: Blood oxygenation at the optic nerve head

Secondary outcome: Origin of visual field defect in Fabry patients

Detailed 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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Universite de Montreal, Montreal, Quebec H3T1P1, Canada
Additional Information

web site of the School of Optometry University of Montreal

Related publications:

Pitz S, Grube-Einwald K, Renieri G, Reinke J. Subclinical optic neuropathy in Fabry disease. Ophthalmic Genet. 2009 Dec;30(4):165-71. doi: 10.3109/13816810903148004.

Kumagai K, Mitamura Y, Mizunoya S, Fujimoto N, Yamamoto S. A case of anterior ischemic optic neuropathy associated with Fabry's disease. Jpn J Ophthalmol. 2008 Sep-Oct;52(5):421-3. doi: 10.1007/s10384-008-0572-4. Epub 2008 Nov 11.

Feke GT, Riva CE. Laser Doppler measurements of blood velocity in human retinal vessels. J Opt Soc Am. 1978 Apr;68(4):526-31.

Diaconu V. Multichannel spectroreflectometry: a noninvasive method for assessment of on-line hemoglobin derivatives. Appl Opt. 2009 Apr 1;48(10):D52-61.

Starting date: August 2014
Last updated: June 2, 2015

Page last updated: August 23, 2015

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