Ignite Creation Date:
2025-12-24 @ 12:18 PM
Ignite Modification Date:
2025-12-27 @ 10:07 PM
Study NCT ID:
NCT01695161
Status:
UNKNOWN
Last Update Posted:
2013-03-01
First Post:
2012-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-invasive Assessment of Intraocular Pressure in MPS by Use of the Ocular Response Analyzer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009083', 'term': 'Mucopolysaccharidoses'}, {'id': 'D000795', 'term': 'Fabry Disease'}], 'ancestors': [{'id': 'D002239', 'term': 'Carbohydrate Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D016464', 'term': 'Lysosomal Storage Diseases'}, {'id': 'D017520', 'term': 'Mucinoses'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D013106', 'term': 'Sphingolipidoses'}, {'id': 'D020140', 'term': 'Lysosomal Storage Diseases, Nervous System'}, {'id': 'D020739', 'term': 'Brain Diseases, Metabolic, Inborn'}, {'id': 'D001928', 'term': 'Brain Diseases, Metabolic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D059345', 'term': 'Cerebral Small Vessel Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D008064', 'term': 'Lipidoses'}, {'id': 'D008052', 'term': 'Lipid Metabolism, Inborn Errors'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-02', 'lastUpdateSubmitDate': '2013-02-28', 'studyFirstSubmitDate': '2012-09-25', 'studyFirstSubmitQcDate': '2012-09-26', 'lastUpdatePostDateStruct': {'date': '2013-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'agreement between ccIOP and GAT in MPS, Fabry and healthy controls', 'timeFrame': 'Sep 2013 (anticipated)', 'description': 'Evaluation of agreement between ccIOP and GAT in MPS, Fabry and healthy controls'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mucopolysaccharidosis', 'Fabry disease'], 'conditions': ['Mucopolysaccharidosis', 'Fabry Disease']}, 'referencesModule': {'references': [{'pmid': '28081172', 'type': 'DERIVED', 'citation': 'Wasielica-Poslednik J, Politino G, Schmidtmann I, Lorenz K, Bell K, Pfeiffer N, Pitz S. Influence of Corneal Opacity on Intraocular Pressure Assessment in Patients with Lysosomal Storage Diseases. PLoS One. 2017 Jan 12;12(1):e0168698. doi: 10.1371/journal.pone.0168698. eCollection 2017.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to compare intraocular pressure (IOP) values assessed with Ocular Response Analyzer to the classical gold standard of IOP measurement, to Goldmann applanation tonometry by mucopolysacchyridosis-, Fabry-patients and healthy controls. We want to investigate biomechanical characteristics of the cornea and their influence on the IOP-measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '25 eyes of MPS patients 25 eyes of Fabry patients 25 eyes of healthy age matched controls (a difference of ± 5 years in the mean between both groups is accepted)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MPS I, II, IV, VI patients with at least grade 3 of corneal clouding (Couprie et al.)\n* Fabry patients with cornea verticillata \\> grade 1\n* Age ≥ 12 years\n* Patient is able to comply with the study procedure\n* Patient has consented to be in the trial\n* Ability to fixate a target\n\nExclusion Criteria:\n\n* History of corneal transplantation or refractive surgery\n* Corneal pathologies other than MPS-associated corneal opacity\n* Corneal, conjunctival or intraocular inflammation'}, 'identificationModule': {'nctId': 'NCT01695161', 'acronym': 'MPSORA', 'briefTitle': 'Non-invasive Assessment of Intraocular Pressure in MPS by Use of the Ocular Response Analyzer.', 'organization': {'class': 'OTHER', 'fullName': 'Johannes Gutenberg University Mainz'}, 'officialTitle': 'Corneal-Compensated Intraocular Pressure, Corneal Hysteresis and Corneal Resistance Factor Measurements Performed With the Ocular Response Analyzer and Their Correlation to Conventional Goldmann Applanation Tonometry.', 'orgStudyIdInfo': {'id': 'MZ-MPS-2012-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'mucopolysaccharidosis', 'description': 'mucopolysaccharidosis'}, {'label': 'Fabry disease', 'description': 'Fabry disease'}, {'label': 'healthy controls', 'description': 'healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '55131', 'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Joanna Wasielica-Poslednik, MD', 'role': 'CONTACT', 'email': 'joanna.wasielica-poslednik@unimedizin-mainz.de', 'phone': '00496131173367'}], 'facility': 'Department of Ophthalmology, University Medical Center, Johannes Gutenberg-', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}], 'overallOfficials': [{'name': 'Susanne Pitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology, University Medical Center, Johannes Gutenberg-'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johannes Gutenberg University Mainz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Susanne Pitz', 'investigatorAffiliation': 'Johannes Gutenberg University Mainz'}}}}