[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractive-disorders\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractive-disorders":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100596824","evaluation-of-the-effects-of-virtual-reality-on-preoperative-anxiety-in-refractive-surgery-100596824",false,"NCT07050498","Evaluation of the Effects of Virtual Reality on Preoperative Anxiety in Refractive Surgery","ERVAN","Inclusion Criteria:\n\n* Patient aged 18 years or older,\n* Patient who has read and signed the consent form for participation in the study after a reflection period (between 10 and 45 minutes)\n* Patient who is a candidate for refractive surgery\n\nExclusion Criteria:\n\n* Contraindication to virtual reality (uncontrolled epilepsy, hearing impairment)\n* Pregnant or breastfeeding patient\n* Cushing's disease, Addison's disease, hypo- or hyperthyroidism\n* Patient treated with topical or systemic corticosteroids\n* Patient treated with neuroleptics, anxiolytics, or antidepressants\n* Patient under legal protection, guardianship, or curatorship\n* Patient participating in another blinded research study\n* Patient not affiliated with the French social security system\n* Patient unable to understand the information provided and\u002For give written informed consent: dementia, psychosis, impaired consciousness, non-French-speaking patient","ALL","18 Years",{"count":19,"type":20},68,"ESTIMATED","INTERVENTIONAL",[23],"NA","The objective of this study is to determine to what extent the use of a software application prior to refractive surgery involving multisensory immersion (visual and auditory) in a hypnotic and relaxing sound and visual environment can reduce anxiety levels.\n\nThe assessment of preoperative anxiety levels will be based on the administration of a psychometric scale (APAIS scale) and the measurement of salivary cortisol, which is a sensitive marker of the patient's stress level.",[26],"Refractive Disorders",[28],"refractive surgery","RECRUITING","2025-06-24",{"date":32,"type":33},"2025-07-03","ACTUAL",{"date":35,"type":33},"2024-09-18",{"date":37,"type":20},"2026-09-18",{"name":39,"class":40},"GCS Ramsay Santé pour l'Enseignement et la Recherche","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":61,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":41},"100596484","algorithm-assisted-subjective-refraction-program-dedicated-to-children-100596484","NCT07046065","Algorithm-assisted Subjective Refraction Program Dedicated to Children","Inclusion Criteria:\n\n1. Age between 6 and 12 years\n2. Subject able to recognize and name the letters of the Latin alphabet\n3. Pupillary distance (PD) not less than 49mm\n4. Distance refractive error for spherical equivalence (SE) within the range of \\[-6.00 to +6.00 D\\] maximum of the two absolute values RE and LE; Cyl ≤ 3.00 D\n5. Monocular Visual acuity ≥ +0.30 LogMAR (0.5 Decimal VA) in each eye at distance\n6. Visual acuity difference \\\u003C 0.20 logMAR between right and left eyes at distance\n\nExclusion Criteria:\n\n1. Vulnerability of the subject\n2. Amblyopia\n3. Strabismus\n4. Any current or evolving pathology manifested in the eye or the appendages which might have an influence on vision, or interfere with refractive state\n5. Any previous ocular surgery, which might have an influence on vision or interfere with study assessments (e.g. iridectomy, refractive surgery…)\n6. Any ocular or systemic condition known to affect refractive status (e.g., keratoconus, diabetes, Down's syndrome, etc.)\n7. Any neurological or speech disorders that might interfere with the ability to understand and answer questions or communicate with the ECP\n8. Any untreated and\u002For uncontrolled systemic condition which might have an influence on vision or interfere with study assessments\n9. Current use of ocular or systemic medications, which, in the Investigator's opinion, may significantly affect pupil size, accommodation or refractive state\n10. History of myopia control intervention that may affect refractive assessment (e.g., atropine, orthokeratology, rigid gas permeable lenses (RGP) etc.) except myopia control spectacles\n11. Contraindications of cycloplegia (e.g. high Intra-ocular pressure - more than 22mmHg in either eye, narrow anterior angle, history of allergy to cycloplegic agents or seizures, etc)\n12. Aphakic or pseudoaphakic (intraocular lens),\n13. Prismatic prescription in either Right or Left eye (horizontal or vertical). -",true,"6 Years","12 Years",{"count":52,"type":20},166,[23],"Current refraction assessment in children is dependent on the Eye Care Specialist and lacks standardization. Essilor has developed new algorithm assisted subjective refraction software dedicated to children of 6-12 years old and suitable for use with Vision-S™ and Vision-R™ phoropters, in addition to existing software.\n\nTwo different versions of the software have been developed: the first incorporating only the steps needed to perform an entire subjective refraction process (vA), and the second, identical to the first but incorporating additional steps useful for managing the child's attention and cooperation (vB).\n\nThe software performance in terms of subjective refraction results will be compared to a conventional subjective refraction method performed with the Vision-R™700 phoropter in manual mode.",[56,26,57,58,59,60],"Refractive Assessment","Hyperopia and Myopia","Astigmatism","Refractive Error Correction","Children",[62,63,64],"cycloplegic refraction","non-cycloplegic refraction","subjective refraction","2025-06-23",{"date":67,"type":33},"2025-07-01",{"date":69,"type":33},"2025-05-23",{"date":71,"type":20},"2025-12-31",{"name":73,"class":74},"Essilor International","INDUSTRY"]