[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632317":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":31,"collaborators":26,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":26,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":26,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":53,"overallStatus":60,"whyStopped":26,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":26},{"fullName":5,"class":6},"Zhongshan Ophthalmic Center, Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Non-compensation group","ACTIVE_COMPARATOR","Subjects underwent SMILE surgery on the VisuMax 800 platform. Preoperative offset coordinates (x, y) were measured; however, while preserving the directional sign, no kappa-angle-based laser centration compensation was applied intraoperatively, and the treatment center was set according to the system's default centration method. Except for the difference in compensation strategy, all other surgical procedures and postoperative management were identical to those in the compensation group.",[13],"Procedure: Apply no compensation to the Kappa angle",{"label":15,"type":16,"description":17,"interventionNames":18},"Compensation group","EXPERIMENTAL","Subjects underwent SMILE surgery on the VisuMax 800 platform. Preoperative offset coordinates (x, y) were measured, and, while preserving the directional sign, a fixed intraoperative laser centration compensation of 0.1 mm was uniformly applied to all eligible study eyes to achieve a quantitative adjustment of the treatment center toward the visual axis. Except for the difference in compensation strategy, all other surgical procedures and postoperative management were identical to those in the non-compensation group.",[19],"Procedure: Apply compensation to the Kappa angle.",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Apply compensation to the Kappa angle.","SMILE PRO is an upgraded version\u002Fprocedural designation of SMILE (Small Incision Lenticule Extraction) performed on the ZEISS VisuMax 800 femtosecond laser platform and remains, in essence, an all-femtosecond corneal refractive procedure. Its basic principle is to use a femtosecond laser to create a lenticule within the corneal stroma together with a small incision, and then remove the lenticule through that incision, thereby reshaping the corneal curvature to correct myopia and astigmatism. In the compensation group, during preoperative parameter input, a fixed intraoperative laser centration compensation of 0.1 mm was uniformly applied to all study eyes meeting the inclusion criteria to achieve a quantitative adjustment of the treatment center toward the visual axis.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Apply no compensation to the Kappa angle","SMILE PRO is an upgraded version\u002Fprocedural designation of SMILE (Small Incision Lenticule Extraction) performed on the ZEISS VisuMax 800 femtosecond laser platform and remains, in essence, an all-femtosecond corneal refractive procedure. Its basic principle is to use a femtosecond laser to create a lenticule within the corneal stroma together with a small incision, and then remove the lenticule through that incision, thereby reshaping the corneal curvature to correct myopia and astigmatism. In the non-compensation group, no kappa-angle-based laser centration compensation was applied intraoperatively, and the treatment center was set according to the system's default centration method.",[9],{"type":32,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100632317","the-impact-of-a-miss-is-as-good-as-a-mile-is-compensation-necessary-for-minimal-ocular-deviation-in-myopic-laser-surgery-100632317",false,"NCT07512115","The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?","Effect of Centration Compensation on Visual Quality in VisuMax 800 SMILE for Small Kappa Angles: A Randomized Trial","Inclusion Criteria:\n\n1. Patients aged 18 to 40 years with myopia or myopic astigmatism and stable refraction for \\>=1 year, whose refractive errors fall within the treatable range of and meet the indications for SMILE surgery.\n2. Normal corneal morphology and corneal thickness meeting surgical requirements.\n3. Preoperative corrected distance visual acuity (CDVA) \\>= 1.0.\n4. Preoperative synthetic Kappa angle offset measured \\>= 0.10 mm and \\\u003C 0.20 mm.\n5. Voluntarily agree to undergo SMILE surgery on the VISUMAX 800 platform, understand the randomization scheme, and provide signed informed consent.\n\nExclusion Criteria:\n\n1. History of prior ocular surgery, significant ocular trauma, or presence of corneal or ocular diseases that may affect the safety of refractive surgery.\n2. Severe systemic diseases that may affect ocular healing or surgical safety.\n3. Females who are pregnant or lactating.\n4. Inability to cooperate as required to complete the procedure or follow-up visits.","ALL","18 Years","40 Years",{"count":44,"type":45},224,"ESTIMATED","INTERVENTIONAL",[48],"NA","The goal of this clinical trial is to evaluate the effect of intraoperative kappa-angle compensation on postoperative visual quality in patients undergoing small incision lenticule extraction (SMILE) using the VisuMax 800 platform. The study will enroll patients with myopia and a kappa-angle offset \\\u003C 0.2 mm.\n\nThe main questions it aims to answer are:\n\nDoes intraoperative kappa-angle compensation reduce postoperative higher-order aberrations after SMILE? Does kappa-angle compensation improve postoperative visual quality and refractive outcomes compared with no compensation?\n\nResearchers will compare SMILE with intraoperative kappa-angle compensation to SMILE without compensation to determine whether compensation leads to better optical quality and visual performance.\n\nParticipants will:\n\nUndergo SMILE surgery with or without intraoperative kappa-angle compensation Complete scheduled postoperative examinations at 1 week, 1 month, 3 months, and 6 months after surgery Receive measurements of visual acuity, refraction, higher-order aberrations, contrast sensitivity, and safety outcomes",[51,52],"Myopia","Refractive Ametropia",[54,55,56,57,58,59],"myopia","SMILE","Refractive Surgery","Randomized Clinical Trial","Angle Kappa","VisuMax 800","NOT_YET_RECRUITING","2026-03-31",{"date":63,"type":64},"2026-04-06","ACTUAL",{"date":66,"type":45},"2026-04-01",{"date":68,"type":45},"2027-05-30",{"name":5,"class":6}]