clinical trial · NCT02023086

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

Université de Montréal·—·completed·n = 8

Fabry DiseaseContrast sensitivity measurementSlit Lamp assessment and intra-ocular pressure measurementVisual field testingOxygen flow at the optic nerve head measurementTropicamideOSOME

brief summary

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.

started

Aug 1, 2014

primary completion

Sep 1, 2016

completion

Sep 1, 2016

last updated

Sep 19, 2024

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

official title

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

full record on clinicaltrials.gov ↗

sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol