Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-04-14 @ 5:50 AM
Study NCT ID:
NCT01884805
Status:
TERMINATED
Last Update Posted:
2019-07-16
First Post:
2013-05-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006956', 'term': 'Hyperopia'}], 'ancestors': [{'id': 'D012030', 'term': 'Refractive Errors'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-12', 'studyFirstSubmitDate': '2013-05-24', 'studyFirstSubmitQcDate': '2013-06-21', 'lastUpdatePostDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of optical aberrations', 'timeFrame': '1 day (Participants will be followed for the duration of ophtalmology consultation)', 'description': 'Feasibility of Measurement of optical aberrations in hyperopia by using an Adaptive Optics Visual Simulator AOVIS-I. Outcome measure is assessed during a consultation'}], 'secondaryOutcomes': [{'measure': 'Reproductibility of the measures', 'timeFrame': '1 day (Participants will be followed for the duration of ophtalmology consultation)', 'description': 'Evaluate the reproducibility of the measures obtained in hyperopic eyes. Outcome measure is assessed during a consultation'}, {'measure': 'Quantitative measurement of optical aberrations', 'timeFrame': '1 day (Participants will be followed for the duration of ophtalmology consultation)', 'description': 'Expression of optical aberrations in numerical measures. Outcome measure is assessed during a consultation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Adaptive Optics Visual Simulator', 'Wavefront aberrometer', 'Optical Aberrations', 'Hyperopia'], 'conditions': ['Hyperopia']}, 'referencesModule': {'references': [{'pmid': '12361172', 'type': 'BACKGROUND', 'citation': 'Fernandez EJ, Manzanera S, Piers P, Artal P. Adaptive optics visual simulator. J Refract Surg. 2002 Sep-Oct;18(5):S634-8. doi: 10.3928/1081-597X-20020901-27.'}, {'pmid': '15557473', 'type': 'BACKGROUND', 'citation': 'Piers PA, Fernandez EJ, Manzanera S, Norrby S, Artal P. Adaptive optics simulation of intraocular lenses with modified spherical aberration. Invest Ophthalmol Vis Sci. 2004 Dec;45(12):4601-10. doi: 10.1167/iovs.04-0234.'}, {'pmid': '17889766', 'type': 'BACKGROUND', 'citation': 'Piers PA, Manzanera S, Prieto PM, Gorceix N, Artal P. Use of adaptive optics to determine the optimal ocular spherical aberration. J Cataract Refract Surg. 2007 Oct;33(10):1721-6. doi: 10.1016/j.jcrs.2007.08.001.'}, {'pmid': '19550905', 'type': 'BACKGROUND', 'citation': 'Manzanera S, Prieto PM, Ayala DB, Lindacher JM, Artal P. Liquid crystal Adaptive Optics Visual Simulator: Application to testing and design of ophthalmic optical elements. Opt Express. 2007 Nov 26;15(24):16177-88. doi: 10.1364/oe.15.016177.'}, {'pmid': '18552387', 'type': 'BACKGROUND', 'citation': 'Villegas EA, Alcon E, Artal P. Optical quality of the eye in subjects with normal and excellent visual acuity. Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4688-96. doi: 10.1167/iovs.08-2316. Epub 2008 Jun 14.'}, {'pmid': '19550501', 'type': 'BACKGROUND', 'citation': 'Fernandez EJ, Prieto PM, Artal P. Wave-aberration control with a liquid crystal on silicon (LCOS) spatial phase modulator. Opt Express. 2009 Jun 22;17(13):11013-25. doi: 10.1364/oe.17.011013.'}, {'pmid': '19724513', 'type': 'BACKGROUND', 'citation': 'Fernandez EJ, Prieto PM, Artal P. Binocular adaptive optics visual simulator. Opt Lett. 2009 Sep 1;34(17):2628-30. doi: 10.1364/OL.34.002628.'}, {'pmid': '19757958', 'type': 'BACKGROUND', 'citation': 'Perez GM, Manzanera S, Artal P. Impact of scattering and spherical aberration in contrast sensitivity. J Vis. 2009 Mar 25;9(3):19.1-10. doi: 10.1167/9.3.19.'}, {'pmid': '20090810', 'type': 'BACKGROUND', 'citation': 'Bueno JM, Acosta E, Schwarz C, Artal P. Wavefront measurements of phase plates combining a point-diffraction interferometer and a Hartmann-Shack sensor. Appl Opt. 2010 Jan 20;49(3):450-6. doi: 10.1364/AO.49.000450.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose of the protocol is to evaluate the adaptive optics visual simulator to measure optical aberrations in hyperopic eyes.\n\nThe study hypotheses are the:\n\n* Ability to measure optical aberrations in hypermetropia.\n* Knowledge of optical aberrations of the eye hyperopic.\n* To adapt therapeutic management in optical aberrations measured.', 'detailedDescription': 'The procedure is guided by the custom made software and its graphical user interface. The interface has been designed to be user-friendly, being very similar to the software usually managed by the clinicians in their daily professional practice. The complete procedure in one patient takes less than 5 minutes and is completely non-invasive. The optical measurements only involve the use of low power infrared laser and the visual testing is as simple for the patients as watching television and making responses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* hyperopic patients\n* to be able to understand an information and give a consent\n* affiliated to medical insurance\n\nExclusion Criteria:\n\n* pregnant women or nursing mothers\n* ocular infection\n* keratitis\n* restless patients\n* ocular surgery 90 days before inclusion'}, 'identificationModule': {'nctId': 'NCT01884805', 'acronym': 'HyperVOPTICA', 'briefTitle': 'Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Feasibility of Measurement of Optical Aberrations in Hyperopia by Using an Adaptive Optics Visual Simulator (AOVIS-I)', 'orgStudyIdInfo': {'id': '12 483 03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Monocular Adaptive Optics Visual Simulator (AOVIS-I)', 'interventionNames': ['Device: Monocular Adaptive Optics Visual Simulator (AOVIS-I)']}], 'interventions': [{'name': 'Monocular Adaptive Optics Visual Simulator (AOVIS-I)', 'type': 'DEVICE', 'description': 'The procedure is guided by the custom made software and its graphical user interface. The interface has been designed to be user-friendly, being very similar to the software usually managed by the clinicians in their daily professional practice. The complete procedure in one patient takes less than 5 minutes and is completely non-invasive. The optical measurements only involve the use of low power infrared laser and the visual testing is as simple for the patients as watching television and making responses.', 'armGroupLabels': ['Monocular Adaptive Optics Visual Simulator (AOVIS-I)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'state': 'Midi-Pyrenees', 'country': 'France', 'facility': 'University Hospital, Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'François MALECAZE, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre de Référence National du Kératocône', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}