[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621614":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":26,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":26,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":35,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Instituto de Oftalmología Fundación Conde de Valenciana","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Corneal Wavefront Guided PRK + CXL","EXPERIMENTAL","Corneal wavefront guided therapeutic PRK (50 µm) with Schwind AMARIS, followed by accelerated epi-off CXL. Intensity: 30 mW\u002Fcm² (pulsed 1 s on \u002F 1 s off; 50% duty cycle). Total energy (fluence): 5.4 J\u002Fcm². Total time (elapsed): 6 minutes \\[equivalent to 3 minutes \"on\" time\\].",[13,14],"Device: Schwind AMARIS excimer laser","Procedure: Corneal collagen crosslinking epi-off accelerated",{"label":16,"type":17,"description":18,"interventionNames":19},"PTK + CXL","ACTIVE_COMPARATOR","Epithelial removal by PTK using Schwind AMARIS, followed by accelerated epi-off CXL. Intensity: 30 mW\u002Fcm² (pulsed 1 s on \u002F 1 s off; 50% duty cycle). Total energy (fluence): 5.4 J\u002Fcm². Total time (elapsed): 6 minutes \\[equivalent to 3 minutes \"on\" time\\].",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Schwind AMARIS excimer laser","Used for corneal wavefront guided PRK therapeutic ablation (50 µm) or for PTK epithelial removal, according to arm assignment.",[9,16],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Corneal collagen crosslinking epi-off accelerated","Riboflavin-UVA crosslinking performed after epithelial removal (corneal wavefront guided PRK arm via PRK; comparator arm via PTK). Intensity: 30 mW\u002Fcm² (pulsed 1 s on \u002F 1 s off; 50% duty cycle). Total energy (fluence): 5.4 J\u002Fcm². Total time (elapsed): 6 minutes \\[equivalent to 3 minutes \"on\" time\\].",[9,16],[33],{"facility":34,"status":35,"city":36,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Instituto de Oftalmología FAP Conde de Valenciana, IAP Sede Centro","RECRUITING","Mexico City","06800","Mexico","MX",{"type":41,"coordinates":42},"Point",[43,44],-99.12766,19.42847,{"lat":44,"lon":43},[47],{"name":48,"role":49,"phone":50,"phoneExt":26,"email":51},"José Carlos JC Guerrero Acosta, MD","CONTACT","3314662291","jc.guerrero1226@gmail.com",{"type":53,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100621614","protect-corneal-wavefront-guided-prk--epi-off-cxl-vs-ptkepi-off-cxl-in-keratoconus-100621614",false,"NCT07372911","PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus","Corneal Wavefront Guided PRK Combined With Epi-off Corneal Cross-Linking Versus Epi-off Corneal Cross-Linking With PTK Epithelial Removal in Keratoconus: A Randomized Clinical Trial","PRoTECT","Inclusion Criteria:\n\n* Age 18-40 years\n* Diagnosis of keratoconus, ABCD Belin stage I-III at baseline\n* Minimum (thinnest) corneal pachymetry ≥ 450 µm pre-op\n* Written informed consent\n* Age-stratified progression requirements:\n* 18-25 y: keratoconus stage I-III (progression not mandatory)\n* 25-35 y: documented progression (meet ≥ 2 Table-1 criteria below) or, if recent documentation is absent, high-risk features for future progression: Kmax \\> 53 D, strong family history, severe atopy with persistent eye rubbing, or any of the following over 12 months: ΔKmax ≥ 1.0 D, thinnest pachymetry decrease ≥ 10 µm, or increase in manifest cylinder ≥ 1.0 D\n* 35-40 y: clear, unequivocal recent progression (meet ≥ 2 Table-1 criteria); late-onset documented progression may be considered\n\nExclusion Criteria:\n\n* Central corneal scars or opacities\n* Prior ocular surgery or trauma (exception: prior LASIK if it is the cause of post-surgical ectasia, per protocol text)\n* Autoimmune disease or uncontrolled diabetes mellitus\n* Pregnancy or lactation\n* Contact lens wear within 2 weeks before baseline evaluation","ALL","18 Years",{"count":65,"type":66},50,"ESTIMATED","INTERVENTIONAL",[69],"NA","Keratoconus causes irregular astigmatism and reduced vision. Epi-off corneal crosslinking (CXL) stabilizes the cornea but often leaves higher-order aberrations uncorrected. This randomized, parallel-group trial compares corneal wavefront guided photorefractive keratectomy (corneal wavefront guided PRK, 50 µm therapeutic ablation) combined with accelerated epi-off CXL versus epi-off CXL with epithelial removal by phototherapeutic keratectomy (PTK) using a Schwind AMARIS excimer laser, in adults with keratoconus. The primary endpoint is change in best-corrected distance visual acuity (logMAR) at 12 months. Key secondary endpoints include Kmax, corneal higher-order aberrations, manifest refraction, Scheimpflug densitometry (haze) and Fantes grade, Corvis ST biomechanics, NEI VFQ-25, and endothelial cell density by non-contact specular microscopy at 1, 3, 6 and 12 months.",[72],"Keratoconus",[72,74,75,76,77,78,79,80,81,82,23,83,84,85,86,87,88,89,90,91,92,93,94,95],"Corneal ectasia","Corneal cross-linking","Corneal collagen crosslinking (CXL)","Epi-off CXL","Riboflavin UV-A","Topography-guided PRK","TG-PRK","Phototherapeutic keratectomy (PTK)","PTK epithelial removal","Excimer laser","Athens Protocol (TG-PRK + CXL)","Crete protocol (PTK + CXL)","Pentacam Scheimpflug tomography","Kmax","Higher-order aberrations (HOAs)","Corneal haze","Specular microscopy","Endothelial cell density","NEI VFQ-25","Visual acuity (logMAR)","Randomized clinical trial","Parallel assignment","2026-01-20",{"date":98,"type":99},"2026-01-28","ACTUAL",{"date":101,"type":99},"2025-09-01",{"date":103,"type":66},"2027-12-30",{"name":5,"class":6},1]