Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-03 @ 8:20 PM
Study NCT ID:
NCT02700295
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2016-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009216', 'term': 'Myopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2016-02-24', 'studyFirstSubmitQcDate': '2016-03-01', 'lastUpdatePostDateStruct': {'date': '2022-04-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative changes in the corneal thickness', 'timeFrame': '1 year'}, {'measure': 'Qualitative changes in the corneal structure', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Quantitative changes in the choroidal thickness', 'timeFrame': '1 year'}, {'measure': 'Qualitative changes in the choroidal structure', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Orthokeratology'], 'conditions': ['Myopia']}, 'descriptionModule': {'briefSummary': 'Orthokeratology has the benefit for slowing down myopia progression and enabling unaided vision during the day. To investigate proposed possible changes of conventional and multifocal orthokeratology in the cornea and choroid this study will image both structures with high resolution optical coherence tomographs over a six month period. Findings will help to plan larger trials over a longer period of time in adults and teenagers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '10 healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged over 18 years\n* Myopia defined as between -1D and -6 D with an increase of 0.5D within the last 18months prior to inclusion\n* Prospect orthokeratology contact lens wearers\n* Normal findings in the slit lamp examination, no corneal pathologies\n\nExclusion Criteria:\n\n* Participation in a clinical trial in the previous 3 weeks\n* Presence of any abnormalities (such as refractive surgery) preventing reliable measurements as judged by the investigator\n* Current contact lens wearers\n* Pregnancy, planned pregnancy or lactating'}, 'identificationModule': {'nctId': 'NCT02700295', 'briefTitle': 'Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Long Term Effects of Multifocal Orthokeratology on Corneal and Choroidal Structures in Healthy Subjects With Myopia- A Pilot Study', 'orgStudyIdInfo': {'id': 'OPHT-260514'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Orthokeratology contact lens group', 'interventionNames': ['Device: Orthokeratology lens']}], 'interventions': [{'name': 'Orthokeratology lens', 'type': 'DEVICE', 'armGroupLabels': ['Orthokeratology contact lens group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Gerhard Garhöfer, Assoc. Prof. PD Dr', 'role': 'CONTACT'}, {'name': 'Gerhard Garhöfer, Assoc. Prof. PD Dr', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wolfgang Drexler, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Center for Medical Physics and Biomedical Engineering, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Gerhard Garhöfer, Assoc. Prof. PD Dr', 'role': 'CONTACT', 'email': 'gerhard.garhoefer@meduniwien.ac.at', 'phone': '+43 1 4040029810'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Gerhard Garhofer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}