[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636542":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":38,"locations":44,"responsibleParty":238,"collaborators":240,"id":244,"slug":245,"hasResults":246,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":249,"eligibilityCriteria":250,"healthyVolunteers":251,"sex":252,"minAge":253,"maxAge":254,"enrollmentInfo":255,"targetDuration":26,"studyType":258,"phases":259,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":275},{"fullName":5,"class":6},"Ohio State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"0.05% Atropine","EXPERIMENTAL","0.05% atropine instilled in each eye nightly at bedtime",[13],"Drug: Atropine Sulfate 0.05% Oph Soln",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo drops instilled in each eye nightly at bedtime",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Atropine Sulfate 0.05% Oph Soln","Atropine Sulfate 0.05% Oph Soln compounded at the pharmacy",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Placebo drop with same formulation as treatment minus the atropine",[15],[31,35],{"name":32,"affiliation":33,"role":34},"David A Berntsen, OD PhD","University of Houston College of Optometry","STUDY_CHAIR",{"name":36,"affiliation":37,"role":34},"Jeffrey J Walline, OD PhD","The Ohio State University College of Optometry",[39],{"name":40,"role":41,"phone":42,"phoneExt":26,"email":43},"Lisa A Jordan, PhD","CONTACT","614-247-7321","jordan.646@osu.edu",[45,64,79,93,108,123,138,153,167,182,195,209,224],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University of Alabama School of Optometry","RECRUITING","Birmingham","Alabama","35233","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-86.80249,33.52066,{"lat":57,"lon":56},[60],{"name":61,"role":41,"phone":62,"phoneExt":26,"email":63},"Sindhu Gurrala","205-975-3881","OPT-donutstudy@uab.edu",{"facility":65,"status":47,"city":66,"state":67,"zip":68,"country":51,"countryCode":52,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"University of California, Berkeley, School of Optometry","Berkeley","California","94720",{"type":54,"coordinates":70},[71,72],-122.27275,37.87159,{"lat":72,"lon":71},[75],{"name":76,"role":41,"phone":77,"phoneExt":26,"email":78},"Yoofi Mensah","510-207-4758","donut@berkeley.edu",{"facility":80,"status":47,"city":81,"state":67,"zip":82,"country":51,"countryCode":52,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Southern California College of Optometry at Marshall B. Ketchum University","Fullerton","92831",{"type":54,"coordinates":84},[85,86],-117.92534,33.87029,{"lat":86,"lon":85},[89],{"name":90,"role":41,"phone":91,"phoneExt":26,"email":92},"Susan Parker","714-463-7580","research@ketchum.edu",{"facility":94,"status":95,"city":96,"state":67,"zip":97,"country":51,"countryCode":52,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"Stanford University","NOT_YET_RECRUITING","Palo Alto","94303",{"type":54,"coordinates":99},[100,101],-122.14302,37.44188,{"lat":101,"lon":100},[104],{"name":105,"role":41,"phone":106,"phoneExt":26,"email":107},"Tawna Roberts, OD PhD","650-498-3154","tawnar@stanford.edu",{"facility":109,"status":47,"city":110,"state":111,"zip":112,"country":51,"countryCode":52,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Illinois College of Optometry","Chicago","Illinois","60616",{"type":54,"coordinates":114},[115,116],-87.65005,41.85003,{"lat":116,"lon":115},[119],{"name":120,"role":41,"phone":121,"phoneExt":26,"email":122},"Jessica Martinez","312-949-7340","Research@ico.edu",{"facility":124,"status":47,"city":125,"state":126,"zip":127,"country":51,"countryCode":52,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Indiana University","Bloomington","Indiana","47405",{"type":54,"coordinates":129},[130,131],-86.52639,39.16533,{"lat":131,"lon":130},[134],{"name":135,"role":41,"phone":136,"phoneExt":26,"email":137},"Amy Peterson, OD","812-856-0242","peteramy@iu.edu",{"facility":139,"status":47,"city":140,"state":141,"zip":142,"country":51,"countryCode":52,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"New England College of Optometry","Boston","Massachusetts","02115",{"type":54,"coordinates":144},[145,146],-71.05977,42.35843,{"lat":146,"lon":145},[149],{"name":150,"role":41,"phone":151,"phoneExt":26,"email":152},"Tamara Khanjyan","617-587-5723","donutstudy@neco.edu",{"facility":154,"status":47,"city":155,"state":155,"zip":156,"country":51,"countryCode":52,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"State University of New York College of Optometry","New York","10036",{"type":54,"coordinates":158},[159,160],-74.00597,40.71427,{"lat":160,"lon":159},[163],{"name":164,"role":41,"phone":165,"phoneExt":26,"email":166},"Keyana Hunte","212-938-4052","clinicresearch@sunyopt.edu",{"facility":168,"status":95,"city":169,"state":170,"zip":171,"country":51,"countryCode":52,"cosmosGeoPoint":172,"geoPoint":176,"contacts":177},"Case Western Reserve Department of Ophthalmology","Cleveland","Ohio","44106",{"type":54,"coordinates":173},[174,175],-81.69541,41.4995,{"lat":175,"lon":174},[178],{"name":179,"role":41,"phone":180,"phoneExt":26,"email":181},"Adam J Peiffer, OD","440-684-1743","adam.peiffer@uhhospitals.org",{"facility":37,"status":47,"city":183,"state":170,"zip":184,"country":51,"countryCode":52,"cosmosGeoPoint":185,"geoPoint":189,"contacts":190},"Columbus","43210",{"type":54,"coordinates":186},[187,188],-82.99879,39.96118,{"lat":188,"lon":187},[191],{"name":192,"role":41,"phone":193,"phoneExt":26,"email":194},"Alexis Koston","614-292-0200","OPT-DonutStudy@osu.edu",{"facility":196,"status":95,"city":197,"state":198,"zip":199,"country":51,"countryCode":52,"cosmosGeoPoint":200,"geoPoint":204,"contacts":205},"Pennsylvania College of Optometry at Drexel University","Elkins Park","Pennsylvania","19027",{"type":54,"coordinates":201},[202,203],-75.12684,40.07706,{"lat":203,"lon":202},[206],{"name":207,"role":41,"phone":26,"phoneExt":26,"email":208},"Erin Jenewein, OD, MS","ej468@drexel.edu",{"facility":210,"status":47,"city":211,"state":212,"zip":213,"country":51,"countryCode":52,"cosmosGeoPoint":214,"geoPoint":218,"contacts":219},"Southern College of Optometry","Memphis","Tennessee","38104",{"type":54,"coordinates":215},[216,217],-90.04898,35.14953,{"lat":217,"lon":216},[220],{"name":221,"role":41,"phone":222,"phoneExt":26,"email":223},"Elaine Turcotte","901-730-5004","eturcotte@sco.edu",{"facility":33,"status":47,"city":225,"state":226,"zip":227,"country":51,"countryCode":52,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"Houston","Texas","77004",{"type":54,"coordinates":229},[230,231],-95.36327,29.76328,{"lat":231,"lon":230},[234],{"name":235,"role":41,"phone":236,"phoneExt":26,"email":237},"Onose Okoeguale","713-743-1994","donut@uh.edu",{"type":239,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[241],{"name":242,"class":243},"National Eye Institute (NEI)","NIH","100636542","phase-3-delaying-the-onset-of-nearsightedness-until-treatment-donut-clinical-trial-100636542",false,"NCT07567040","Delaying the Onset of Nearsightedness Until Treatment (DONUT) Clinical Trial","DONUT","Inclusion Criteria:\n\n* Refractive Error (cycloplegic autorefraction, spherical equivalent, at least one eye, inclusive) 6 years: -0.74 D to +0.75 D 7 and 8 years: -0.74 D to +0.50 D 9 and 10 years: -0.74 D to +0.25 D 11 years: -0.74 D to plano\n* Neither eye has -0.75 D or more myopia, spherical component\n* Anisometropia: Less than 1.50 D difference between OD and OS, cycloplegic autorefraction, spherical equivalent\n* Astigmatism: Less than 1.50 DC in both eyes by cycloplegic autorefraction\n* Successfully complete run-in period: take at least 90% of unit dose artificial tears for 2 to 4 weeks (# of unit-dose vials used divided by # nights since baseline visit must equal 0.90 or greater)\n\nExclusion Criteria:\n\n* If Visit 2 (randomization visit) is not completed within 4 weeks of the baseline, eligibility visit.\n* Presence of strabismus (intermittent or constant) based on unilateral cover test at distance and near\n* Known allergy to atropine\n* Systemic issues that may affect accommodation or convergence (e.g., multiple sclerosis, myasthenia gravis, Graves ophthalmopathy, diabetes mellitus, Parkinson's disease, Down syndrome, etc.)\n* Ocular disease (e.g., congenital glaucoma, retinal disease, nystagmus, amblyopia, etc.)\n* Ocular surgery (e.g., cataracts, strabismus)\n* Any previous myopia prevention\u002Fcontrol therapy (e.g., atropine, soft contact lenses, orthokeratology, myopia control spectacles, etc.) for more than one month\n* Pregnancy by self-report",true,"ALL","6 Years","11 Years",{"count":256,"type":257},664,"ESTIMATED","INTERVENTIONAL",[260],"PHASE3","The aims of this clinical trial will test whether or not the onset of nearsightedness is delayed in a group of children randomized to nightly drops in 0.05% atropine in both eyes, in comparison to children who receiving nightly placebo drops in both eyes. The primary outcome is the two-year cumulative incidence of nearsightedness. The second aim of this project will determine whether atropine is associated with slower eye growth in children receiving nightly drops of atropine versus placebo.",[263],"Myopia",[265],"prevention","2026-08-19",{"date":268,"type":269},"2026-08-21","ACTUAL",{"date":271,"type":269},"2026-05-27",{"date":273,"type":257},"2028-05-15",{"name":5,"class":6},13]