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
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