[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654839":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":21,"studyPopulation":21,"armGroups":28,"interventions":39,"overallOfficials":21,"centralContacts":48,"locations":56,"responsibleParty":69,"collaborators":21,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":21,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":21,"overallStatus":91,"whyStopped":21,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"Axial length","Axial length measured using the IOL Master® biometer","1 year",[14,17],{"measure":15,"description":16,"timeFrame":12},"Spherical equivalent","Spherical equivalent calculated from refraction measurements taken using an autorefractometer under cycloplegia",{"measure":18,"description":19,"timeFrame":20},"pourcentage of changement in optical correction","Percentage of patients who required a change in their optical correction (due to the progression of myopia) at least once during the 2-year follow-up period","2 years",null,{"allocation":23,"interventionModel":24,"interventionModelDescription":21,"primaryPurpose":25,"observationalModel":21,"timePerspective":21,"maskingInfo":26},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":27,"maskingDescription":21,"whoMasked":21},"NONE",[29,34],{"label":30,"type":31,"description":21,"interventionNames":32},"Essilor® Stellest® 2.0 myopia-slowing lenses","EXPERIMENTAL",[33],"Device: Essilor® Stellest® 2.0 myopia-slowing lenses",{"label":35,"type":36,"description":21,"interventionNames":37},"standard lenses","ACTIVE_COMPARATOR",[38],"Device: Standard lenses",[40,44],{"type":41,"name":30,"description":42,"armGroupLabels":43,"otherNames":21},"DEVICE","Essilor® Stellest® 2.0 myopia-slowing lenses will be worn continuously throughout the day for the two-year follow-up period of the study, i.e. from the time the eyewear (lenses and frames) is dispensed until the end of the follow-up period. It is recommended that the eyewear be worn for at least 12 hours a day, every day.",[30],{"type":41,"name":45,"description":46,"armGroupLabels":47,"otherNames":21},"Standard lenses","Standard lenses (Airwear single-vision lenses) will be worn continuously throughout the day during the two-year follow-up period of the study, i.e. from the time the eyewear (lenses and frames) is issued until the end of the follow-up period. It is recommended that the eyewear be worn for at least 12 hours a day, every day.",[35],[49,53],{"name":50,"role":51,"phone":21,"phoneExt":21,"email":52},"Elise Philippakis","CONTACT","ephilippakis@for.paris",{"name":54,"role":51,"phone":21,"phoneExt":21,"email":55},"Vivien Vasseur","vvasseur@for.paris",[57],{"facility":58,"status":21,"city":59,"state":21,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":21},"Hopital Fondation A de Rothschild","Paris","75019","France","FR",{"type":64,"coordinates":65},"Point",[66,67],2.3488,48.85341,{"lat":67,"lon":66},{"type":70,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100654839","efficacy-of-myopia-control-lenses-in-a-population-of-young-adults--the-optima-study-100654839",false,"NCT07804043","Efficacy of Myopia-control Lenses in a Population of Young Adults : the OPTIMA Study","Efficacité de Verres de Freination Myopique Dans Une Population de Jeunes Adultes","OPTIMA","Inclusion Criteria:\n\n* Spherical equivalent (SE) measured under cycloplegia using an autorefractometer, within the range 4 D ≤ SE ≤ -0.75 D for each eye\n* Not currently receiving, nor having received, any preventive treatment for myopic progression in the 12 months prior to inclusion (orthokeratology, soft defocus contact lenses, low-concentration atropine eye drops, corrective spectacles with peripheral defocus)\n* Myopic progression of at least -0.25 D in at least one eye during the year prior to inclusion (measurements documented by autorefractometer, with or without cycloplegia, or via previous optical prescriptions) or documented progression of axial length of +0.1 mm during the year prior to inclusion\n* Primary optical correction via spectacles (occasional use of contact lenses if applicable) or agreement to wear spectacles for at least 12 hours a day, every day\n* Enrolled in or a beneficiary of a social security scheme\n* Signed informed consent to participate in the study by the adult patient or by a person with parental authority for minor patients\n\nExclusion Criteria:\n\n* Confirmed syndromic myopia or findings suggestive of syndromic myopia\n* Obvious strabismus or significant heterophoria\n* Corrected visual acuity \\\u003C 8\u002F10 in at least one eye\n* A history of eye surgery (excluding eyelid surgery) in at least one eye\n* Hyperopia or non-myopic astigmatism\n* Anisometropia, i.e. a marked difference in correction between the two eyes\n* Advanced retinal disease in at least one eye, such as myopic maculopathy\n* Specific visual impairments in at least one eye requiring personalised treatments other than conventional corrective lenses\n* Intolerance to optical corrections (conventional lenses or lenses with peripheral defocus)\n* Patients subject to legal protection measures\n* Pregnant or breastfeeding women\n* Participation in another interventional clinical trial (drug clinical trial)","ALL","16 Years","25 Years",{"count":83,"type":84},134,"ESTIMATED","INTERVENTIONAL",[87],"NA","The goal of this clinical trial is to learn if myopia-control eyeglass lenses (Essilor® Stellest® 2.0) can slow down the progression of short-sightedness (myopia) in young adults, compared with standard single-vision lenses. The main questions it aims to answer are:\n\nDoes wearing Stellest® 2.0 lenses slow the increase in eye length (axial length) after 1 year, compared with standard lenses? Does wearing Stellest® 2.0 lenses reduce the change in glasses prescription and the occurrence of eye complications after 2 years, compared with standard lenses? How well do participants tolerate the Stellest® 2.0 lenses in the first weeks of wear? Researchers will compare Stellest® 2.0 myopia-control lenses to standard single-vision lenses to see if they reduce the worsening of myopia.\n\nParticipants will:\n\nWear either the study glasses or standard glasses every day, at least 12 hours a day, for 2 years Attend an eye exam and vision check at the start of the study, after 1 year, and after 2 years Complete three phone check-ins during the first 3 months to report on comfort and how well they tolerate their glasses",[90],"Myopia","NOT_YET_RECRUITING","2026-08-31",{"date":94,"type":95},"2026-09-04","ACTUAL",{"date":97,"type":84},"2026-11-01",{"date":99,"type":84},"2030-12-01",{"name":5,"class":6},1]