Ocular Surface Metabolo-lipidomics in Lateral Amyotrophic Sclerosis
NCT ID: NCT04953286
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2021-09-17
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Case group
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
Measure of visual acuity
ETDRS and Parinaud scale
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
Samples of basal tears
Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary
Central corneal sensitivity
Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)
Slit lamp examination and undilated fundus
Slit lamp examination and undilated fundus
Conjunctival impression
Conjunctival impression with anesthetic instillation
Evaluation of the corneal innervation
Contact corneal confocal microscopy
Control group
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
Measure of visual acuity
ETDRS and Parinaud scale
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
Samples of basal tears
Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary
Central corneal sensitivity
Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)
Slit lamp examination and undilated fundus
Slit lamp examination and undilated fundus
Conjunctival impression
Conjunctival impression with anesthetic instillation
Evaluation of the corneal innervation
Contact corneal confocal microscopy
Interventions
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Measure of visual acuity
ETDRS and Parinaud scale
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
Samples of basal tears
Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary
Central corneal sensitivity
Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)
Slit lamp examination and undilated fundus
Slit lamp examination and undilated fundus
Conjunctival impression
Conjunctival impression with anesthetic instillation
Evaluation of the corneal innervation
Contact corneal confocal microscopy
Eligibility Criteria
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Inclusion Criteria
* Familial or sporadic form
* ≥18 years of age
* Patient affiliated with a social security plan
* Informed consent signed by the patient
* 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 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:
* 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
18 Years
100 Years
ALL
Yes
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Locations
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Ophthalmology Department, University Hospital of Tours, France
Tours, , France
Neurology Department, University Hospital of Tours, France
Tours, , France
Centre d'Investigation Clinique_CIC 1415
Tours, , France
Countries
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References
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Khanna RK, Catanese S, Mortemousque G, Dupuy C, Lefevre A, Emond P, Beltran S, Gissot V, Pisella PJ, Blasco H, Corcia P. Metabolomics of basal tears in amyotrophic lateral sclerosis: A cross-sectional study. Ocul Surf. 2024 Oct;34:363-369. doi: 10.1016/j.jtos.2024.09.005. Epub 2024 Sep 28.
Other Identifiers
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DR210051
Identifier Type: -
Identifier Source: org_study_id