[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100608418":3},{"organization":4,"armGroups":7,"interventions":37,"overallOfficials":56,"centralContacts":60,"locations":69,"responsibleParty":88,"collaborators":43,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":43,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":43,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":72,"whyStopped":43,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":132},{"fullName":5,"class":6},"Hoopes Vision","OTHER",[8,15,19,24,28,33],{"label":9,"type":10,"description":11,"interventionNames":12},"ARM 1: Ray Tracing Guided LASIK in OD and Keratorefractive Lenticule Extraction in OS","ACTIVE_COMPARATOR","Subjects receive Ray Tracing Guided LASIK in the RIGHT EYE and Keratorefractive Lenticule Extraction in the LEFT EYE",[13,14],"Device: Ray-Tracing Guided LASIK","Device: Keratorefractive Lenticule Extraction (KLEx)",{"label":16,"type":10,"description":17,"interventionNames":18},"ARM 2: WaveLight Plus LASIK in OS and Keratorefractive Lenticule Extraction in OD","Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Keratorefractive Lenticule Extraction in the RIGHT EYE",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"ARM 3: Ray Tracing Guided LASIK in OD and Wavefront Optimized LASIK in OS","Subjects receive Ray Tracing Guided LASIK in the RIGHT EYE and Wavefront Optimized LASIK in the LEFT EYE.",[13,23],"Device: WaveFront Optimized LASIK",{"label":25,"type":10,"description":26,"interventionNames":27},"ARM 4: Ray Tracing Guided LASIK in OS and Wavefront Optimized LASIK in OD","Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Wavefront Optimized LASIK in the RIGHT EYE",[13,23],{"label":29,"type":10,"description":30,"interventionNames":31},"ARM 5: Ray Tracing Guided LASIK in OD and Topography Guided LASIK in OS","Subjects receive Ray Tracing Guided in the RIGHT EYE and Topography Guided LASIK in the LEFT EYE",[13,32],"Device: Topography Guided LASIK",{"label":34,"type":10,"description":35,"interventionNames":36},"ARM 6: Ray Tracing Guided LASIK in OS and Topography Guided LASIK in OD","Subjects receive Ray Tracing Guided LASIK in the LEFT EYE and Topography Guided LASIK in the RIGHT EYE",[13,32],[38,44,48,52],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"DEVICE","Ray-Tracing Guided LASIK","A form of LASIK where Ray-Tracing technology is used to create the surgical profile for treating the cornea.",[9,16,20,25,29,34],null,{"type":39,"name":45,"description":46,"armGroupLabels":47,"otherNames":43},"Keratorefractive Lenticule Extraction (KLEx)","A form of corneal refractive surgery utilizing a femtosecond laser to create a lens shaped lenticule of corneal tissue that is removed through a small corneal incision.",[9,16],{"type":39,"name":49,"description":50,"armGroupLabels":51,"otherNames":43},"WaveFront Optimized LASIK","A form of LASIK where the corneal treatment profile is modified to decrease induced Spherical Aberration.",[20,25],{"type":39,"name":53,"description":54,"armGroupLabels":55,"otherNames":43},"Topography Guided LASIK","A form of LASIK where a corneal topography of the cornea is used to create the surgical profile for treating the cornea.",[29,34],[57],{"name":58,"affiliation":5,"role":59},"Majid Moshirfar, MD","PRINCIPAL_INVESTIGATOR",[61,66],{"name":62,"role":63,"phone":64,"phoneExt":43,"email":65},"Steven H Linn, OD","CONTACT","801-988-7342","slinn@hoopesvision.com",{"name":67,"role":63,"phone":64,"phoneExt":43,"email":68},"Shealynn Petersen, BS","sheapetersen@hoopesvision.com",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Hoopes Moshirfar Research Center","RECRUITING","Draper","Utah","84020","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-111.86382,40.52467,{"lat":82,"lon":81},[85,86,87],{"name":62,"role":63,"phone":64,"phoneExt":43,"email":65},{"name":67,"role":63,"phone":64,"phoneExt":43,"email":68},{"name":58,"role":59,"phone":43,"phoneExt":43,"email":43},{"type":89,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100608418","a-three-phase-contralateral-comparison-of-ray-tracing-guided-lasik-versus-three-other-refractive-surgery-platforms-to-correct-myopia-or-myopia-with-astigmatism-100608418",false,"NCT07201298","A Three-Phase Contralateral Comparison of Ray-Tracing Guided LASIK Versus Three Other Refractive Surgery Platforms to Correct Myopia or Myopia With Astigmatism","A Prospective Contralateral Comparison of Ray-Tracing Guided LASIK (WaveLight® Plus LASIK) vs. Small Incision Lenticule Extraction (SMILE® Pro) Using VisuMax® 800, or Wavefront Optimized LASIK or Topography Guided LASIK (Contoura LASIK): A Three-Phase Visual Outcomes Study.","Inclusion Criteria:\n\n1. Age 22-50 at the time of consent\n2. Diagnosis of myopia or myopia with astigmatism with Preoperative manifest spherical equivalent refraction of ≥ -2.00 and ≤ -9.00 D (-2.00 D through -9.00 D)\n3. Preop Spherical component of ≥ -2.00 and ≤ -8.00 D (-2.00 D through -8.00 D)\n4. Refractive Cylinder of ≤ -3.00 D (0.00 through -3.00 D)\n5. BCVA of 20\u002F20 or better in each eye (83 or more letters on the ETDRS Chart)\n6. Subjects must have a stable refraction which is defined as a change in spherical equivalent no greater than 0.50 D comparing the screening visit manifest refraction to a previous refraction, spectacle Rx, or contact lens Rx, 12 months or older.\n7. Subjects who are contact lens wearers must discontinue the use of soft lenses (spherical or toric) for at least 5 days and hard or gas-permeable lenses for at least 4 weeks prior to the preoperative screening evaluation. Hard or gas-permeable lens wearers must not return to contact lens use before surgery. Soft lens wearers may resume contact lens wear after all preoperative testing is completed, but must discontinue lens use at least 5 days before surgery.\n8. Acceptable preoperative tomography and examination results for refractive procedures as determined by the Principal Investigator.\n9. Surgical plan includes treatment target for emmetropia in both eyes, and no monovision.\n10. Subject is capable and willing to use postoperative medications as prescribed.\n11. Subject has ability to successfully complete all preoperative and postoperative questionnaires, testing, and exam visits.\n12. Subject is willing and able to return for all postoperative examinations.\n\nExclusion Criteria:\n\n1. Clinically significant dry eye on clinical examination, as determined by the investigator\n2. Irregular astigmatism, keratoconus, keratoconus suspect, or abnormal corneal tomography\n3. History of corneal dystrophies or guttata\n4. History of herpetic keratitis or active disease\n5. History of prior refractive surgery\n6. History of glaucoma or glaucoma suspect\n7. History of uncontrolled diabetes, unstable hypertension, or unstable autoimmune disease.\n8. Females who are pregnant, breastfeeding, or intend to become pregnant any time during the study as determined by verbal inquiry.\n9. The Principal Investigator has determined the subject not to be a good candidate for the study.",true,"ALL","22 Years","50 Years",{"count":102,"type":103},120,"ESTIMATED","INTERVENTIONAL",[106],"NA","This purpose of this study is to compare a new form of LASIK called Ray Tracing Guided LASIK to 3 other forms of corneal refractive surgery: 1. KLEx (KeratoLenticule Extraction) using the Zeiss Visumax 800 Laser, 2. WFO LASIK (Wavefront Optimized LASIK) using the Alcon EX500 Laser, and 3. Topography Guided LASIK (Contoura LASIK) also using the Alcon EX500 Laser.",[109,110],"Myopia","Astigmatism",[112,113,114,115,116,117,118,119,120,121,53,122],"refractive surgery","myopia","astigmatism","excimer laser","femtosecond laser","Ray Tracing","Lenticule","SMILE","KLEx","Contoura","Wavefront Optimized","2025-09-23",{"date":125,"type":126},"2025-10-01","ACTUAL",{"date":128,"type":103},"2025-09",{"date":130,"type":103},"2029-09",{"name":5,"class":6},1]