NCT04953286

Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis

Tear Fluid and Ocular Surface Metabolomics and Lipidomics in Lateral Amyotrophic Sclerosis: a Prospective Comparative Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: University Hospital, Tours · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
OTHER	Measure of visual acuity	ETDRS and Parinaud scale
OTHER	Interferometry	Non-contact exam measuring N.I.B.U.T (Non-invasive break-up time), quantitative and qualitative evaluation of the meibomian glands and quantitative evaluation of the tear meniscus
OTHER	Samples of basal tears	Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary
OTHER	Central corneal sensitivity	Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)
OTHER	Slit lamp examination and undilated fundus	Slit lamp examination and undilated fundus
OTHER	Conjunctival impression	Conjunctival impression with anesthetic instillation
OTHER	Evaluation of the corneal innervation	Contact corneal confocal microscopy

Timeline

• Start date: 2021-09-17
• Primary completion: 2023-09-30
• Completion: 2023-09-30
• First posted: 2021-07-07
• Last updated: 2025-12-22

Locations

3 sites across 1 country: France