[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"aberration-corneal-wavefront\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:aberration-corneal-wavefront":33},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100559512","clinical-investigation-for-a-multifunction-ophthalmic-measurement-device-100559512",false,"NCT06565091","Clinical Investigation for a Multifunction Ophthalmic Measurement Device","Development Clinical Investigation for a Multifunction Ophthalmic Measurement Device","Inclusion Criteria:\n\nAdults ≥ 18 years old and Healthy children\\* ≥ 4 years and \\\u003C18 of age.\n\nParticipants initially coming to the center for a routine consultation\n\nParticipants who are affiliated to a social security scheme or beneficiaries of such a scheme (L. 1121-8-1 of the Public Health Code of \"Code de Santé Publique\"),\n\nParticipants able to sit upright in front of the investigational device.\n\nInclusion Criteria\\* (for Healthy children):\n\nHealthy children ≥ 4 years and \\\u003C18 of age. The parents must have consented to their child's participation.\n\nChildren who are affiliated to parent's social security scheme or beneficiaries of such a scheme (L. 1121-8-1 of the Public Health Code of \"Code de Santé Publique\")\n\nChildren initially coming to the center for a routine consultation\n\nChildren able to sit upright in front of the instrument.\n\nExclusion Criteria:\n\nParticipants with implanted electronic medical device such as pacemaker, insulin pump, cochlear implant, electrostimulator or hearing aid,\n\nParticipants not able to sit upright in front of the instrument or subjects with forehead or chin injuries which prevent the head from being supported on the forehead \u002F chin rest.\n\nParticipants who are deprived of their liberty by judicial or administrative decision and persons hospitalized without their consent (Article L. 1121-6 of \"Code de Santé Publique\"),\n\nParticipants who are subject to a legal protection measure (curatorship, guardianship, safeguard of justice ...) or unable to express their consent (Article L1121-8 of \"Code de Santé Publique\"),\n\nParticipants who are not affiliated to a social security scheme or beneficiaries of such a scheme (L. 1121-8-1 of the Public Health Code of \"Code de Santé Publique\"),\n\nParticipants under exclusion period from another investigation,\n\nWomen who are pregnant or breastfeeding women; (Article L1121-5 of \"Code de Santé Publique\"). No additional risk had been identified for pregnant woman in participating in the investigation. Nevertheless, pregnancy induces ocular changes: in case of AE, the causality with the device or with pregnancy may be difficult to establish, justifying the non-inclusion of this population.\n\nParticipants with neurologic disorder, particularly epileptic or sensory motor troubles,\n\nParticipants with history of recent ocular surgeries (including refractive surgery less than 2 weeks),\n\nParticipants who are ESSILOR International\u002FESSILOR Luxottica employees,\n\nParticipants with monophthalmia,\n\nParticipants with obvious fixation disorder, strabismus, or nystagmus,\n\nFor tonometry measurements: subjects who have: Edematous\u002Fulcerated cornea, following keratoplasty or ocular surgery, following penetrating trauma, severe Keratoconus with risk of hydrops and in case of retinal detachment. Anterior and posterior chamber sulcus IOL, intrastromal rings or lens (type Kamra).\n\nParticipants with pupil \\\u003C 2 mm,\n\nParticipants who are with spherical equivalent refraction out of the range -20.00 to + 20.00 D (frontofocometer measurement),\n\nParticipants with an astigmatism greater than 8.00 D (\\\u003C8.00 D) (frontofocometer measurement),\n\nParticipants with corneal power out of the range \\[35-55D\\],\n\nParticipants with axial length out of the range \\[18-34 mm\\],\n\nParticipants with Intraocular pressure out of \\[7-50 mm Hg\\] range,\n\nParticipants to a previous phase of this clinical investigation.\n\nExclusion Criteria (for Healthy children):\n\nChildren with neurologic disorders, particularly epileptic or sensory motor troubles,\n\nChildren with history of recent ocular surgeries (including refractive surgery less than two weeks)\n\nChildren with monophthalmia,\n\nChildren with obvious fixation disorder, strabismus, or nystagmus,\n\nChildren with pupil \\\u003C 2 mm\n\nChildren with a spherical equivalent refraction out of the range \\[-20.00 to + 20.00 D\\] (frontofocometer measurement),\n\nChildren with an astigmatism higher than 8.00 D (\\>8.00 D)\n\nChildren with axial length out of the range \\[18-34 mm\\]",true,"ALL","4 Years",{"count":20,"type":21},378,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this clinical investigation is to evaluate the clinical utility of a multifunctional measuring device for Ophtalmology.\n\nThe results of this clinical investigation will be used to refine and validate the device design.\n\n378 participants total will be included in the trial, each having only one visit at the investigation center.",[27,28,29,30,31,32,33],"Accommodation Disorder","Keratoconus","Dry Eye","Refractive Errors","Accommodative Fatigue","Accommodative Inertia","Aberration, Corneal Wavefront","RECRUITING","2024-08-19",{"date":37,"type":38},"2024-08-21","ACTUAL",{"date":40,"type":38},"2024-06-10",{"date":42,"type":21},"2025-08",{"name":44,"class":45},"Essilor International","INDUSTRY"]