Study Purpose:
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 ALSStudy Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
Measure of visual acuity, Interferometry, Samples of basal tears, Central corneal sensitivity, Slit lamp examination and undilated fundus, Conjunctival impression, Evaluation of the corneal innervation
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Raoul Kanav KHANNA, MD / email hidden; JavaScript is required / 02.47.47.37.24
Study Sponsor:
University Hospital, Tours
Estimated Enrollment:
60
Estimated Study Start Date:
09 / 17 / 2021
Estimated Study Completion Date:
01 / 01 / 2024
Posting Last Modified Date:
01 / 26 / 2023
Date Study Added to neals.org:
07 / 07 / 2021
Minimum Age:
18 Years
Maximum Age:
100 Years
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
Ophthalmology Department, University Hospital of Tours, France | Recruiting
Raoul K Khanna, MD / 0247472767 / email hidden; JavaScript is required
Tours 37000
France
Neurology Department, University Hospital of Tours, France | Recruiting
Philippe CORCIA, MD-PhD
Principal Investigator : Philippe CORCIA, MD-PhD
Tours 37044
France
Centre d'Investigation Clinique_CIC 1415 | Not yet recruiting
Valérie GISSOT, MD
Principal Investigator : Valérie GISSOT, MD
Tours
France