Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis (LARMOMIQUE)

Regional University Hospital Center (CHRU)

Status: Completed

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Other: Slit lamp examination and undilated fundus; Other: Samples of basal tears; Other: Evaluation of the corneal innervation; Other: Central corneal sensitivity; Other: Conjunctival impression; Other: Measure of visual acuity; Other: Interferometry

Study type: Interventional

Funder types: Other

Identifiers

NCT04953286

DR210051

Details and patient eligibility

About

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

Enrollment: 55 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55 participants in 2 patient groups

Case group

Other group

Description:

The procedure, specific to the study, consists in taking samples of tears and cells at inclusion, 3 months after inclusion and 6 months after inclusion on patients with Amyotrophic Lateral Sclerosis

Treatment:

Other: Interferometry

Other: Measure of visual acuity

Other: Conjunctival impression

Other: Central corneal sensitivity

Other: Evaluation of the corneal innervation

Other: Samples of basal tears

Other: Slit lamp examination and undilated fundus

Control group

Other group

Description:

The procedure, specific to the study, consists in taking samples of tears and cells at inclusion, 3 months after inclusion and 6 months after inclusion on patients without neurological disease

Treatment:

Other: Interferometry

Other: Measure of visual acuity

Other: Conjunctival impression

Other: Central corneal sensitivity

Other: Evaluation of the corneal innervation

Other: Samples of basal tears

Other: Slit lamp examination and undilated fundus