Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2026-03-11 @ 4:43 PM
Study NCT ID:
NCT03285204
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2017-03-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2020-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2017-09-12', 'lastUpdatePostDateStruct': {'date': '2019-02-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia", 'timeFrame': 'change from baseline to 6 month', 'description': 'macular, ganglion cell layer and retinal nerve fiber layer thickness measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['optical coherence tomography', 'amyotrophic lateral sclerosis'], 'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': "The aim of this study is to obtain an early biomarker of amyotrophic lateral sclerosis and Friedreich's Ataxia which allows to diagnose the disease in an initial stage and to follow up the patient with optic coherence tomography, a fast, non-invasive and comfortable method", 'detailedDescription': "All patients will be asked about their data and their general medical history, and will be underwent on one hand, a complete neurological examination including the degree of neurological impairment quantified according to the functional rating scale of ALS (ALSFRS-r) or Scale for the assessment and rating of ataxia (SARA); On the other hand, they will have a complete ophthalmological examination too, including the patient's graduation, pupillary and ocular motility examination, biomicroscopy, Goldman tonometry and fundus exam. Patients will be performed too a conventional automated Humprey perimetry, color test (Farnsworth-Munsell 28 Hue Color Vision Test) and finally an optical coherence tomography (OCT) in order to see possible anatomical alterations in both macula and optic nerve. The follow-up of these explorations will be repeated in all cases at 6 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Amyotrophic lateral sclerosis patients Friedreich's ataxia patients Healthy volunteers", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Older than 18 years.\n* Best corrected visual acuity more than 0.4 (20/50 Snellen = 0.4 logMAR = 65 ETDRS letters).\n* Refractive defect less than 5 diopters of spherical equivalent and / or cylinder less than 2 diopters.\n* Transparent optical media: Opacity of crystalline \\<1 according to Lens Opacities Classification System (LOCS) III.\n* Open anterior chamber angle assessed by gonioscopy with Goldmann lens (grade\\> III).\n* Availability and collaboration to carry out the tests of the exploratory protocol.\n* Acceptance of informed consent.\n\nExclusion Criteria:\n\n* Previous intraocular surgeries of less than 6 months of evolution. Patients with refractive surgery using the LASIK or LASEK technique will not be excluded.\n* Physical or mental difficulties to perform reliable and reproducible perimeters.\n* Pathology and / or ocular malformations, angular or optic nerve anomalies.\n* Any retinopathy or maculopathy.\n* Intraocular pressure (IOP)\\> 21 mmHg.\n* Signal-to-noise ratio in OCT less than 5/10.\n* Failure to meet any inclusion criteria.\n* Mental retardation or any other limitation in obtaining informed consent.'}, 'identificationModule': {'nctId': 'NCT03285204', 'briefTitle': "Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia", 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Gregorio Marañon'}, 'officialTitle': "Relationship Between Neurological Disability and Visual Impairment in Patients With ALS or Friedreich's Ataxia", 'orgStudyIdInfo': {'id': 'ELA-AF-OCT-2014-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'ALS patients'}, {'label': 'Friedreich Ataxia patients'}, {'label': 'Healthy control'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28010', 'city': 'Madrid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Pilar Rojas Lozano', 'role': 'CONTACT', 'email': 'pilar.rojas.lozano@gmail.com', 'phone': '+34616042758'}], 'facility': 'Pilar Rojas Lozano', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'centralContacts': [{'name': 'Pilar Rojas, MD', 'role': 'CONTACT', 'email': 'pilar.rojas.lozano@gmail.com', 'phone': '+34616042758'}], 'overallOfficials': [{'name': 'Jose L Urcelay, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'HGU Gregorio Marañón'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jose Luis Urcelay Segura', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head Of ophthalmology', 'investigatorFullName': 'Jose Luis Urcelay Segura', 'investigatorAffiliation': 'Hospital General Universitario Gregorio Marañon'}}}}