[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05486546":3,"trial-entities:NCT05486546":157,"trial-summary:NCT05486546":160},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":48,"secondary_outcomes":53,"sex":69,"minimum_age":70,"maximum_age":71,"healthy_volunteers":15,"eligibility_criteria":72,"std_ages":98,"locations":100,"central_contacts":145,"overall_officials":154,"references":155,"see_also_links":156},"NCT05486546","AMPLIO","Contoura With Phorcides Compared to Wavefront Optimized LASIK","Comparison of Visual Acuity and Quality of Life Following Contoura With Phorcides Compared to WaveLight Wavefront Optimized LASIK","RECRUITING","2023-12-01","2023-04","2023-04-26","2022-08-15","Daniel Terveen","OTHER",false,"Comparing post-operative visual acuity and patient reported satisfaction between Contoura with Phorcides and WaveLight Wavefront Optimized.",null,[19,20],"Myopia","Astigmatism",[22,23,24,25,26,27],"Visual acuity","Refractive outcome","LASIK","Contrast sensitivity","Wavefront Optimized","Topography-guided","INTERVENTIONAL","TREATMENT",[31],"NA",{"count":33,"type":34},120,"ESTIMATED",[36,42],{"type":37,"name":38,"description":39,"armGroupLabels":40},"PROCEDURE","Contoura with Phorcides","Participants that undergo LASIK surgery using Contoura with Phorcides Analytic Engine",[41],"Study: Phorcides",{"type":43,"name":44,"description":45,"armGroupLabels":46},"DEVICE","WaveLight Wavefront Optimized","Participants that undergo LASIK surgery using WaveLight Wavefront Optimized",[47],"Control: Wavefront Optimized",[49],{"measure":50,"description":51,"timeFrame":52},"Post-Op UDVA","Percent of participants with monocular UDVA of 20\u002F16 or better","3 months post-op",[54,57,60,63,66],{"measure":55,"description":56,"timeFrame":52},"Post-OP BCVA","Percent of participants with monocular and binocular BCVA of 20\u002F16 or better",{"measure":58,"description":59,"timeFrame":52},"Residual Refractive Error","Residual astigmatism and residual SE",{"measure":61,"description":62,"timeFrame":52},"Low Contrast Visual Acuity","25% low contrast visual acuity post-op",{"measure":64,"description":65,"timeFrame":52},"Pre-op and post-op visual acuity","Percent of participants with post-op UDVA equal to or better than their pre-op CDVA",{"measure":67,"description":68,"timeFrame":52},"Corrected Distance Visual Acuity","Compare percent of participants with post-operative and pre-operative CDVA","ALL","21 Years","38 Years",{"inclusion":73,"exclusion":86,"raw_text":97},[74,75,76,77,78,79,80,81,82,83,84,85],"Patients at least age 21 years of age undergoing LASIK eye surgery","Willing and able to comprehend informed consent and complete 1 month post-op visit","Potential postoperative BCDVA of 20\u002F20 or better in each eye based on Investigator's medical opinion","Candidates for Contoura with Phorcides (Myopic, astigmatism \\\u003C3.0D)","Both eyes targeted for plano","Pre-operative total corneal Pachymetry 490um or above","Stable refractive error \\\u003C0.50D change in preceding year","Good general and ocular health","Pre-operative exam completed within three months of surgery","SCL discontinued 3 days prior to pre-op exam and the procedure","Pachymetry above 490 with residual greater than 270um","Candidates who, as determined by the investigator, can safely undergo LASIK",[87,88,89,90,91,92,93,94,95,96],"Patients under 21 years of age","Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon","Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)","Pachymetry below 490","Autoimmune or immunodeficiency diseases","Pregnant or nursing women","Patients with signs of inability to understand consent for study and procedure planned","Patients with history of previous ocular surgery","Patients with strabismus or amblyopia","Patients that have a BCDVA of 20\u002F25 or worse in either eye","Inclusion Criteria:\n\n* Patients at least age 21 years of age undergoing LASIK eye surgery\n* Willing and able to comprehend informed consent and complete 1 month post-op visit\n* Potential postoperative BCDVA of 20\u002F20 or better in each eye based on Investigator's medical opinion\n* Candidates for Contoura with Phorcides (Myopic, astigmatism \\\u003C3.0D)\n* Both eyes targeted for plano\n* Pre-operative total corneal Pachymetry 490um or above\n* Stable refractive error \\\u003C0.50D change in preceding year\n* Good general and ocular health\n* Pre-operative exam completed within three months of surgery\n* SCL discontinued 3 days prior to pre-op exam and the procedure\n* Pachymetry above 490 with residual greater than 270um\n* Candidates who, as determined by the investigator, can safely undergo LASIK\n\nExclusion Criteria:\n\n* Patients under 21 years of age\n* Concomitant ocular condition which would limit the BCVA at the discretion of the surgeon\n* Patients with usual relative and absolute contraindications for LASIK surgery (Patients with severe dry eye, recurrent corneal erosion, uncontrolled Glaucoma, collagen vascular disorders, keratoconus or signs of keratoconus, uncontrolled Diabetes, Herpes)\n* Pachymetry below 490\n* Autoimmune or immunodeficiency diseases\n* Pregnant or nursing women\n* Patients with signs of inability to understand consent for study and procedure planned\n* Patients with history of previous ocular surgery\n* Patients with strabismus or amblyopia\n* Patients that have a BCDVA of 20\u002F25 or worse in either eye",[99],"ADULT",[101,116,125,133],{"facility":102,"status":8,"city":103,"state":104,"zip":105,"country":106,"contacts":107,"geoPoint":113},"Vance Thompson Vison","Bozeman","Montana","57105","United States",[108],{"name":109,"role":110,"phone":111,"email":112},"Keeley Boever","CONTACT","402-740-9420","keeley.boever@vancethompsonvision.com",{"lat":114,"lon":115},45.67965,-111.03856,{"facility":117,"status":8,"city":118,"state":119,"zip":105,"country":106,"contacts":120,"geoPoint":122},"Vance Thompson Vision","Omaha","Nebraska",[121],{"name":109,"role":110,"phone":111,"email":112},{"lat":123,"lon":124},41.25626,-95.94043,{"facility":117,"status":8,"city":126,"state":127,"zip":105,"country":106,"contacts":128,"geoPoint":130},"Fargo","North Dakota",[129],{"name":109,"role":110,"phone":111,"email":112},{"lat":131,"lon":132},46.87719,-96.7898,{"facility":117,"status":8,"city":134,"state":135,"zip":136,"country":106,"contacts":137,"geoPoint":142},"Sioux Falls","South Dakota","57108",[138],{"name":139,"role":110,"phone":140,"email":141},"Keeley Puls","605-371-7075","keeley.puls@vancethompsonvision.com",{"lat":143,"lon":144},43.54369,-96.72796,[146,150],{"name":147,"role":110,"phone":148,"email":149},"Daniel Terveen, MD","605-645-7999","daniel.terveen@vancethompsonvision.com",{"name":151,"role":110,"phone":152,"email":153},"Elise Meide, M.S.","605-645-0444","elise.reid@coyotes.usd.edu",[],[],[],{"nct_id":4,"conditions":158,"biomarkers":159},[20,19],[],{"nct_id":4,"found":161,"summary":162,"prompt_version":17},true,{"design":163,"status":164,"heading":165,"summary":166,"follow_up":167,"word_count":168,"commitments":169,"compensation":170,"drugs_mentioned":171},"This interventional study plans to enroll 120 participants to compare two different LASIK procedures.","completed","LASIK Surgery Comparison for Myopia and Astigmatism","This study is comparing two types of LASIK (laser-assisted in situ keratomileusis) eye surgery for people with myopia (nearsightedness) and astigmatism (blurry vision due to an imperfectly shaped eye). You might be able to join if you are between 21 and 38 years old and need LASIK. The study is testing if \"Contoura with Phorcides\" works better than \"WaveLight Wavefront Optimized\" LASIK. Researchers will look at how well you can see without glasses or contacts three months after surgery to see which method is more successful. The current status of this study is unclear, so it's not known if they are actively looking for participants.","Your vision will be measured three months after surgery to assess the primary outcome.",105,"You would undergo LASIK eye surgery and need to complete a one-month post-operative visit.","Not stated in the trial record.",[38,44]]