[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hyperopia-and-myopia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hyperopia-and-myopia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,75],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100618709","eye-imaging-for-the-study-of-childhood-myopia-100618709",false,"NCT07335146","Eye Imaging for the Study of Childhood Myopia","Modélisation de l'œil Myope Infantile Par IRM et OCT","SELENA","Inclusion Criteria:\n\n* Spherical equivalent under cycloplegia greater -6.5 D and less than 2 D\n* Beneficiary of social security\n* Written consent from both holders of parental authority (or from one in case of exclusive parental authority)\n\nExclusion Criteria:\n\n* Declared neurological deficit, including history of epileptic pathology or sensory-motor coordination disorders, vestibular or cerebellar pathology (for example, balance disorders)\n* Current or progressive pathology of the eyes or their appendages that may affect vision, other than myopia (examples: glaucoma, retinitis pigmentosa…)\n* Declared aphakia or pseudophakia (intraocular implant)\n* Ocular motility problem such as strabismus or nystagmus\n* Contraindication to MRI (claustrophobia, implanted devices such as pacemaker, etc.)",true,"ALL","6 Years","12 Years",{"count":22,"type":23},100,"ESTIMATED","INTERVENTIONAL",[26],"NA","Myopia (nearsightedness) is increasing worldwide and is becoming a serious public health problem. Studies estimate that by 2050, if no action is taken, almost half of the world's population will be myopic. About 10% of people could develop severe myopia, which increases the risk of serious eye problems such as retinal detachment, damage to the macula, or glaucoma.\n\nChildren are particularly affected because myopia often worsens as they grow. Several treatments are now available to slow the progression of myopia in children, but these treatments are not equally effective for everyone. Some children respond better than others, and the reasons for these differences are not yet well understood. One possible explanation is that differences in eye anatomy may influence the effectiveness of a treatment. This suggests that myopia treatments may need to be tailored to each child. By studying the anatomy of the eye, researchers could improve and personalize myopia control strategies.\n\nThe study entitled \"Eye imaging for the study of childhood myopia\" aims to better understand the structure of children's eyes. The study will collect clinical data, including images of the eye taken with MRI and measurements of the eye obtained using standard eye examination devices. The data will then be analyzed using image-processing and statistical methods to allow a detailed study of children's eye anatomy.",[29],"Hyperopia and Myopia",[31,32,33],"myopia","eye anatomy","ophthalmological measurements","RECRUITING","2026-03-27",{"date":37,"type":38},"2026-03-30","ACTUAL",{"date":40,"type":38},"2026-02-18",{"date":42,"type":23},"2027-12",{"name":44,"class":45},"Essilor International","INDUSTRY",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":46},"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). -",{"count":54,"type":23},166,[26],"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.",[58,59,29,60,61,62],"Refractive Assessment","Refractive Disorders","Astigmatism","Refractive Error Correction","Children",[64,65,66],"cycloplegic refraction","non-cycloplegic refraction","subjective refraction","2025-06-23",{"date":69,"type":38},"2025-07-01",{"date":71,"type":38},"2025-05-23",{"date":73,"type":23},"2025-12-31",{"name":44,"class":45},{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":18,"minAge":82,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":24,"phases":85,"briefSummary":86,"conditions":87,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":46},"100592713","evaluation-of-a-new-laser-refractive-vision-correction-using-the-teneo-317-model-2-100592713","NCT06997003","Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2","Evaluation of a New Customized Corneal Treatment for Laser Refractive Vision Correction Using the TENEO™ 317 Model 2","Inclusion Criteria:\n\n1. Subjects already scheduled for bilateral refractive laser surgery targeting emmetropia (attempted MRSE is between and including -0.50 D and +0.50 D).\n2. Minimum 18 years of age.\n3. Have read, understood, and signed an informed consent form (ICF).\n4. Have a stable refraction (i.e., a change of ≤ 0.50 D in sphere and cylinder) for both eyes as judged by the investigator.\n5. Have less than 0.75 D spherical equivalent (SE) difference between cycloplegic and manifest refractions at preoperative visit for both eyes.\n6. Study group 1 only: Have hyperopic refractive error with or without astigmatism; sphere between 0.00 D and 4.00 D, cylinder between 0.00 D and 3.00 D for both eyes; with a spherical equivalent (SE) between 0.50 D and 5.50 D for both eyes.\n7. Study groups 2 and 3 only: Have myopic refractive error with or without astigmatism; sphere between -8.00 D and 0.00 D, cylinder between 0.00 D and -4.00 D for both eyes; with a spherical equivalent (SE) between -10.00 D and -1.00 D for both eyes.\n8. Have CDVA of 20\u002F25 (logMAR 0.1) or better in both eyes\n9. Have normal corneal topography as determined by the Investigator for both eyes.\n10. Have discontinued use of contact lenses for at least 2 weeks (for hard lenses) or 3 days (for soft lenses) prior to the pre-operative examination, and through the day of surgery.\n11. All contact lens wearers must demonstrate a stable refraction (within ± 0.50 D), as determined by MRSE, on two consecutive examinations at least 1 week apart, in both eyes and the axis of cylinder should not differ by more than 15 degrees from the baseline cycloplegic refraction for both eyes.\n12. Have the ability to lie flat without difficulty.\n13. Are willing and able to comply with the schedule for all post-surgery follow-up visits.\n\nExclusion Criteria:\n\n1. Subjects for whom the combination of their baseline corneal thickness and the planned operative parameters for the LASIK procedure would result in less than 250 microns residual stroma thickness in any eye.\n2. Tear Break-Up time (TBUT) \\\u003C8 s in any eye.\n3. Mesopic pupil size larger than the optical zone of the planned treatment for any eye.\n4. History or evidence of active or inactive of corneal disease or infection in either eye (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent erosion syndrome, corneal dystrophy, etc.).\n5. Central corneal scars affecting visual acuity or unstable keratometry with irregular mires in any eye.\n6. Irregular astigmatism in any eye.\n7. Keratoconus or suspicion of keratoconus (sub-clinical, forme fruste), corneal dystrophy in any eye.\n8. Previous intraocular or corneal surgery in either eye that might confound the outcome of the study or increase the risk to the subject.\n9. Ocular muscle disorder including a strabismus or nystagmus, or other disorder affecting fixation in any eye.\n10. Evidence of retinal vascular disease in any eye.\n11. History or evidence glaucoma or glaucoma suspect in any eye.\n12. Acute or chronic disease or illness that would increase the operative risk, likely affect the wound healing or confound the outcomes of the study (e.g. immuno-compromised, connective tissue disease, clinically significant atopic disease, diabetes, etc.).\n13. Use chronic systemic medications that may confound the outcome of the study or increase the risk to the subject, including, but not limited to steroids, antimetabolites, etc.;\n14. Take medications contraindicated with LASIK such as isotretinoin (Accutane) or amiodarone hydrochloride (Cordarone).\n15. Known sensitivity to medications used for standard LASIK treatment.\n16. Females of childbearing potential (those who are not surgically sterilized or not postmenopausal for at least 12 months) if they meet one of the following conditions: Pregnant, lactating or unwilling to use effective birth control over the course of the study.\n17. Concurrent or previous (within 30 days) participation in another drug or device investigation.","18 Years",{"count":84,"type":23},81,[26],"Prospective, post market clinical follow up study with a three months postoperative follow up to evaluate the visual and refractive outcomes of OCTAVIUS treatment when used as intended.",[29],"2025-06-19",{"date":90,"type":38},"2025-06-22",{"date":92,"type":38},"2025-06-16",{"date":94,"type":23},"2026-09",{"name":96,"class":45},"Bausch & Lomb GmbH"]