[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100632316":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":37,"acronym":26,"eligibilityCriteria":38,"healthyVolunteers":35,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":26,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":52,"overallStatus":59,"whyStopped":26,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":26},{"fullName":5,"class":6},"Zhongshan Ophthalmic Center, Sun Yat-sen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Low-Level compensation group","ACTIVE_COMPARATOR","Subjects underwent SMILE surgery on the VisuMax 800 platform. Preoperatively, decentration coordinates (x, y) were measured. While preserving the directional sign, the absolute value of the planned compensation was set to 50% of the measured decentration; the values were then rounded to the nearest increment permitted by the device input precision and entered into the system. All other surgical procedures, as well as postoperative medication and follow-up protocols, were performed according to a standardized regimen.",[13],"Procedure: Apply low compensation to the Kappa angle.",{"label":15,"type":16,"description":17,"interventionNames":18},"High-Level compensation group","EXPERIMENTAL","Subjects also underwent SMILE surgery on the VisuMax 800 platform. Decentration coordinates (x, y) were measured, and the theoretical compensation was set at 100% of the measured decentration. While preserving the directional sign, the measured values were entered directly into the device without any additional adjustment. Except for the different compensation strategy, all other surgical procedures and postoperative management were identical to those of the low-compensation group.",[19],"Procedure: Apply high compensation to the Kappa angle.",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Apply high 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. It 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 high-level compensation group, a high level of compensation for the kappa angle was applied during the preoperative parameter input.",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Apply low 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. It is essentially an all-femtosecond corneal refractive procedure. Its basic principle is to use a femtosecond laser to create a lenticule within the corneal stroma and a small incision, and then remove the lenticule through the incision, thereby reshaping the corneal curvature to correct myopia and astigmatism. In the low-level compensation group, a low level of kappa-angle compensation was applied during the preoperative parameter input.",[9],{"type":32,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100632316","comparison-of-low--versus-high-level-angle-kappa-compensation-strategies-in-smile-using-the-visumax-800-a-randomized-clinical-trial-100632316",false,"NCT07512102","Comparison of Low- Versus High-Level Angle Kappa Compensation Strategies in SMILE Using the VisuMax 800: A Randomized Clinical Trial","Inclusion Criteria:\n\n1. Age range: 18 - 40 years old. Patients with stable refractive status for \\>= 1 year, having myopia or myopic astigmatism, with refractive power within the range of SMILE procedure.\n2. Normal corneal morphology and corneal thickness meeting the surgical requirements.\n3. Best corrected visual acuity (CDVA) before surgery \\>= 1.0.\n4. The kappa angle-related offset coordinates (x, y) obtained before surgery, with the absolute value of either \\|x\\| or \\|yl\\| of any eye \\>= 0.20mm.\n5. Voluntary to undergo SMILE surgery on the VISUMAX800 platform, understanding the random grouping scheme and signing the informed consent form.\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":43,"type":44},100,"ESTIMATED","INTERVENTIONAL",[47],"NA","The goal of this clinical trial is to compare two intraoperative kappa-angle compensation strategies during small incision lenticule extraction (SMILE) using the VisuMax 800 platform in patients with relatively large kappa-angle offsets.\n\nAngle kappa represents the difference between the visual axis and the pupil center. In patients with a large offset, pupil-centered treatment may lead to decentration of the optical zone, which can induce higher-order aberrations and affect postoperative visual quality. The VisuMax 800 system allows intraoperative adjustment of the treatment center based on the measured offset, making different compensation strategies possible.\n\nThe main questions this study aims to answer are:\n\nDoes low kappa-angle compensation (50%) result in lower postoperative higher-order aberrations than high compensation (100%)? Does the compensation strategy influence visual acuity, refractive outcomes, contrast sensitivity, and subjective visual quality after SMILE? Are the measurements obtained from different diagnostic devices consistent when evaluating kappa-related parameters?\n\nResearchers will compare SMILE with low compensation to SMILE with high compensation to determine which strategy provides better optical quality and visual performance.\n\nParticipants will:\n\nUndergo SMILE surgery using either low or high kappa-angle compensation Complete scheduled postoperative examinations at 1 month, 3 months, and 6 months Receive measurements of visual acuity, refraction, higher-order aberrations, contrast sensitivity, and patient-reported visual outcomes Be monitored for safety outcomes and adverse events during follow-up",[50,51],"Myopia","Refractive Ametropia",[53,54,55,56,57,58],"myopia","SMILE","Refractive Surgery","Randomized Clinical Trial","Angle Kappa","VisuMax 800","NOT_YET_RECRUITING","2026-03-31",{"date":62,"type":63},"2026-04-06","ACTUAL",{"date":65,"type":44},"2026-04-01",{"date":67,"type":44},"2027-05-30",{"name":5,"class":6}]