[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractive-ametropia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractive-ametropia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,71,87],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100646112","comparison-of-two-rotational-alignment-methods-for-astigmatism-correction-in-smile-surgery-100646112",false,"NCT07696468","Comparison of Two Rotational Alignment Methods for Astigmatism Correction in SMILE Surgery","Comparison of Astigmatic Correction Outcomes Following SMILE With OcuLign-Assisted Cyclotorsion Control and Manual Limbal Marking: A Prospective Randomized Contralateral-Eye Noninferiority Study","Inclusion Criteria:\n\n1. Age range: 18 - 40 years old. Patients with myopic astigmatism and stable refractive status for \\>= 1 year.\n2. Normal corneal morphology in both eyes, with corneal thickness and other ocular parameters meeting the requirements for SMILE surgery.\n3. Preoperative corrected distance visual acuity (CDVA) \\>= 1.0 in both eyes.\n4. Manifest refractive cylinder \\>= 0.75 D in both eyes, with an interocular difference in absolute cylinder power \\\u003C= 1.00 D.\n5. Both eyes can provide reliable preoperative upright-position image information required for astigmatic axis recognition, and are judged by the investigator to meet the requirements for OcuLign cyclotorsion recognition and axis alignment on the VISUMAX 800 platform.\n6. Voluntary to undergo bilateral SMILE surgery on the VISUMAX 800 platform, understanding the random eye-assignment scheme and signing the informed consent form.\n\nExclusion Criteria:\n\n1. History of prior ocular surgery, significant ocular trauma, or presence of ocular diseases that may affect the safety of refractive surgery or the interpretation of study outcomes.\n2. Irregular astigmatism or poor repeatability of bilateral astigmatism measurements, making reliable astigmatic axis analysis impossible.\n3. Presence of strabismus, nystagmus, significant binocular vision abnormality, or any condition that may affect fixation or cooperation during examinations.\n4. Severe systemic diseases that may affect ocular healing or surgical safety.\n5. Females who are pregnant or lactating.\n6. Inability to complete the required postoperative follow-up visits or questionnaire assessments.","ALL","18 Years","40 Years",{"count":20,"type":21},52,"ESTIMATED","INTERVENTIONAL",[24],"NA","Small incision lenticule extraction (SMILE) is a commonly used corneal refractive procedure for correcting myopia and myopic astigmatism. During astigmatism correction, eye rotation between the upright examination position and the supine surgical position may affect the alignment of the astigmatic treatment axis and may contribute to residual astigmatism after surgery.\n\nManual limbal marking is a commonly used method to guide cyclotorsion adjustment during refractive surgery. OcuLign is an assisted cyclotorsion control function of the VISUMAX 800 platform that helps identify ocular rotation and guide axis alignment during SMILE. However, direct clinical evidence comparing OcuLign-assisted cyclotorsion control with manual limbal marking during SMILE is limited.\n\nThis study is a single-center, prospective, randomized, masked, contralateral-eye non-inferiority trial. Adults aged 18 to 40 years with stable myopia and astigmatism who plan to undergo bilateral SMILE surgery will be enrolled. In each participant, one eye will receive SMILE with OcuLign-assisted cyclotorsion control, and the fellow eye will receive SMILE with manual limbal marking-guided cyclotorsion adjustment. The treatment assigned to the right eye will be determined by randomization.\n\nThe primary objective is to compare residual refractive astigmatism at 3 months after surgery between the two methods. Secondary outcomes include visual acuity, refractive predictability and stability, astigmatism vector analysis, higher-order aberrations, contrast sensitivity, patient-reported quality of vision, overall satisfaction, and safety outcomes. Participants will be followed for approximately 6 months after surgery.",[27,28],"Myopia","Refractive Ametropia",[30,31,32,33],"myopia","SMILE","VisuMax 800","Cyclotorsion","NOT_YET_RECRUITING","2026-07-13",{"date":37,"type":38},"2026-07-15","ACTUAL",{"date":35,"type":21},{"date":41,"type":21},"2027-06-30",{"name":43,"class":44},"Zhongshan Ophthalmic Center, Sun Yat-sen University","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":45},"100632317","the-impact-of-a-miss-is-as-good-as-a-mile-is-compensation-necessary-for-minimal-ocular-deviation-in-myopic-laser-surgery-100632317","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.",{"count":54,"type":21},224,[24],"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",[27,28],[30,31,59,60,61,32],"Refractive Surgery","Randomized Clinical Trial","Angle Kappa","RECRUITING","2026-07-05",{"date":65,"type":38},"2026-07-07",{"date":67,"type":38},"2026-04-08",{"date":69,"type":21},"2027-05-30",{"name":43,"class":44},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":77,"targetDuration":4,"studyType":22,"phases":79,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":85,"leadSponsor":86,"locationsCount":45},"100632316","comparison-of-low--versus-high-level-angle-kappa-compensation-strategies-in-smile-using-the-visumax-800-a-randomized-clinical-trial-100632316","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.",{"count":78,"type":21},100,[24],"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",[27,28],[30,31,59,60,61,32],{"date":65,"type":38},{"date":67,"type":38},{"date":69,"type":21},{"name":43,"class":44},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":93,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":22,"phases":96,"briefSummary":97,"conditions":98,"keywords":4,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":108},"100617714","a-study-to-evaluate-the-clinical-performance-and-safety-of-unicon-silicone-hydrogel-daily-disposable-soft-contact-lenses-100617714","NCT07322211","A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses","Inclusion Criteria:\n\n1. Adult with an age ≥ 18;\n2. Be a currently adapted soft contact lens wearer who successful wear of soft contact lenses in both eyes for a minimum of 5 days per week and 6 hours per day within 3 months prior to study screening (by verbal confirmation);\n3. Participant must be stop wearing any contact lenses more than 7 days prior to screening;\n4. Able to wear contact lenses within a range of power from -2.00D to -6.00D (0.25 D steps) in both eyes;\n5. Astigmatism of 1.25D or less in both eyes;\n6. Be correctable to a visual acuity of 1.0 decimal (0.0 logMAR) or better in each eye;\n7. Participant must be able to be successfully fit with study lenses;\n8. The participant must appear able and willing to adhere to the instructions set forth in this clinical protocol;\n9. The participant must read and sign the Informed Consent Form.\n\nExclusion Criteria:\n\n1. Women who are currently pregnant;\n2. Women who are lactating or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit);\n3. Any use of systemic or ocular medications (e.g., non-steroidal anti-inflammatory eye drops, ophthalmic steroids) within 30 days prior to study enrollment for which contact lens wear could be contraindicated, as determined by the investigator;\n4. Any current or history ocular or systemic disease which may interfere with contact lens wear, as determined by the investigator;\n5. Any current or previous orthokeratology treatment within 90 days prior to study enrollment, or planned for orthokeratology treatment during the study;\n6. Any previous history of ocular and\u002For refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) or planned for ocular and\u002For refractive surgery during the study;\n7. Current or history of herpetic keratitis in either eye;\n8. Current or history of intolerance, hypersensitivity or allergy to silicone hydrogel soft contact lenses or any component of the study products;\n9. Current clinical finding of entropion, ectropion, chalazia, recurrent styes, glaucoma, pathologically dry eye (defined as Schirmer test \\\u003C 5 mm\u002F5 min), recurrent corneal erosions, aphakia, or moderate or above corneal distortion;\n10. Employee of Department of Ophthalmology and clinic (e.g., Investigator, Coordinator, Technician);\n11. Participation in any interventional clinical trial within 30 days prior to study enrollment;\n12. Any biomicroscopy findings at screening that are Grade 3 or higher and\u002For corneal neovascularization that is Grade 2 or higher and\u002For presence of corneal infiltrates;\n13. Any history of a contact lens-related corneal inflammatory or infectious event within 12 months prior to study enrollment that may contraindicate contact lens wear;\n14. Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;\n15. Participants are considered ineligible for the study as judged by the investigator.","18 Days",{"count":95,"type":21},35,[24],"13 weeks, open-label, daily disposable contact lens dispensing study.",[28],"2026-01-20",{"date":101,"type":38},"2026-01-22",{"date":99,"type":38},{"date":104,"type":21},"2026-10-31",{"name":106,"class":107},"Unicon Optical Co. Ltd.","INDUSTRY",2]