Clinical trial NCT04953286: Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis
Official title: Tear Fluid and Ocular Surface Metabolomics and Lipidomics in Lateral Amyotrophic Sclerosis: a Prospective Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Keywords: Amyotrophic Lateral Sclerosis
Biomarkers
Ocular Surface
Tear
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2021-07-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Amyotrophic Lateral Sclerosis (ALS) is the most common neurodegenerative disease affecting the motor neuron. Currently, there is no diagnostic test and no examination that can predict the evolution of this pathology. The search for diagnostic and prognostic biomarkers is therefore essential for a better understanding of the pathophysiology of ALS, which remains poorly understood, and also for better clinical management. The ocular surface, made up of liquid elements, tears, and cells, is an accessible anatomical-physiological entity that has demonstrated its usefulness in the identification of biomarkers in neurodegenerative diseases such as Parkinson's or Alzheimer's. To date, no study has explored the ocular surface as a biomarker in ALS


Eligibility criteria: Case group selection criteria :

Inclusion Criteria:

* Patient with clinically defined or probable primary ALS according to Airlie House criteria(1)
* Familial or sporadic form
* ≥18 years of age
* Patient affiliated with a social security plan
* Informed consent signed by the patient

Exclusion Criteria:

* Motor neuron disease mimicking ALS
* Pregnant or breastfeeding woman
* Treatment that may have a neuroprotective effect
* Any eye drops or treatments that may interfere with tear production
* Lens wearer
* Eye surgery ≤3 months
* Any ocular pathology other than ametropia, oculomotor disorder, amblyopia
* Any general pathology other than ALS with ocular repercussions
* Protective measure of guardianship or curators

Control group selection criteria:

Inclusion Criteria:

* No diagnosed neurological pathology
* ≥18 years of age
* Patient affiliated with a social security plan
* Informed consent signed by the participant

Exclusion Criteria:

* Pregnant or breastfeeding woman
* Treatment likely to have a neuroprotective effect
* Any eye drops or treatments that may interfere with tear production
* Lens wearer
* Eye surgery ≤3 months
* Any ocular pathology except ametropia, oculomotor disorder, amblyopia
* Any general pathology with ocular repercussions
* Protective measure of guardianship or curator

Primary outcomes:
measure: Metabolome profile in tears for the diagnosis and prognosis of ALS.
timeFrame: Baseline
measure: Metabolome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
timeFrame: Baseline
measure: Lipidome profile in tears for the diagnosis and prognosis of ALS.
timeFrame: Baseline
measure: Lipidome profile in intra-cellular contents for the diagnosis and prognosis of ALS.
timeFrame: Baseline
Secondary outcomes:
measure: Evolution of the ocular surface metabolites during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
timeFrame: Baseline
measure: Evolution of the ocular surface lipids during ALS progression using ultra-high performance liquid chromatography coupled with mass spectrometry
timeFrame: Baseline
Other outcomes:
Locations:
city: Tours
country: France
facility: Ophthalmology Department, University Hospital of Tours, France
city: Tours
country: France
facility: Neurology Department, University Hospital of Tours, France
city: Tours
country: France
facility: Centre d'Investigation Clinique_CIC 1415
Study officials:
References: