[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593197":3},{"organization":4,"outcomesModule":7,"designInfo":65,"detailedDescription":71,"studyPopulation":64,"armGroups":72,"interventions":85,"overallOfficials":95,"centralContacts":100,"locations":108,"responsibleParty":129,"collaborators":64,"id":132,"slug":64,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":64,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":64,"enrollmentInfo":140,"targetDuration":64,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":110,"whyStopped":64,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":64},[9],{"measure":10,"description":11,"timeFrame":12},"Change in Marginal Reflex Distance 1 (MRD1) at 6 Months","MRD1 will be measured preoperatively and at 6 months postoperatively to assess the difference in eyelid position between the anterior and posterior approach groups.","Baseline (Day 0) and Month 6 (±2 weeks) after surgery",[14,18,22,25,29,32,35,38,42,45,48,52,56,60],{"measure":15,"description":16,"timeFrame":17},"Change in MRD1 at 2 Months","Measured preoperatively and at 2 months postoperatively to compare eyelid position between groups.","Baseline (Day 0) and Month 2 (±1 week) after surgery",{"measure":19,"description":20,"timeFrame":21},"Postoperative Interpalpebral Symmetry at 2 and 6 Months","Symmetry between eyelids will be evaluated to assess aesthetic outcomes.","Month 2 (±1 week) and Month 6 (±2 weeks) after surgery",{"measure":23,"description":24,"timeFrame":21},"Eyelid Contour Evaluation at 2 and 6 Months","Eyelid contour will be assessed using standardized frontal photographs in primary gaze.\n\nObjective analysis will be performed with ImageJ software using the Bézier plugin to calculate the percentage of overlap with an ideal curve (Excellent: \\>90%, Good: 85-90%, Poor: \\\u003C85%).\n\nSubjective assessment will be conducted by three masked investigators based on symmetry, curvature, and slope criteria, rated as Excellent (3\u002F3), Good (2\u002F3), or Poor (0-1\u002F3).",{"measure":26,"description":27,"timeFrame":28},"Change in Refractive Error at 2 and 6 Months","Comparison of pre- and postoperative refractive measurements.","Baseline (Day 0), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery",{"measure":30,"description":31,"timeFrame":28},"Change in Corneal Topographic Parameters at 2 and 6 Months","Assessed using corneal topography to evaluate changes related to surgery.",{"measure":33,"description":34,"timeFrame":28},"Change in Tear Break-Up Time (TBUT) at 2 and 6 Months","Measured to assess the impact on tear film stability. TBUT will be measured by instilling fluorescein dye and recording the time (in seconds) from the last blink to the first appearance of a dry spot on the cornea. Each eye will be assessed three times, and the mean value will be used. Lower values indicate greater tear film instability. A TBUT \\\u003C10 seconds is considered abnormal.",{"measure":36,"description":37,"timeFrame":28},"Change in Schirmer Test (without anesthesia) at 2 and 6 Months","Evaluates tear production before and after surgery. The Schirmer I test (without anesthesia) measures basal and reflex tear production. Standardized strips will be placed in the lower fornix for 5 minutes. The length of wetting (in mm) will be recorded. Values \\\u003C10 mm indicate decreased tear production.",{"measure":39,"description":40,"timeFrame":41},"Change in Ocular Surface Disease Index (OSDI) Scores at 7 Days, 2 and 6 Months","Patient-reported outcomes on dry eye symptoms. The OSDI questionnaire includes 12 items assessing symptoms, visual function, and environmental triggers. Raw scores are converted to a 0-100 scale using the formula: (sum of scores × 25) ÷ number of questions answered. Higher scores indicate greater symptom severity. Classification: 0-12 (normal), 13-22 (mild), 23-32 (moderate), ≥33 (severe).","Baseline (Day 0), Day 7 (±1 day), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery",{"measure":43,"description":44,"timeFrame":17},"Change in Aesthetic Satisfaction Scores at 2 Months","Assessed with the FACE-Q Aesthetics \"Satisfaction with Eyes\" scale. Raw scores are summed and converted to a 0-100 scale using the official Conversion Table. If ≥50% of items are answered, missing values are imputed using the within-person mean. Higher scores indicate greater satisfaction.",{"measure":46,"description":47,"timeFrame":17},"Change in Psychosocial Function Scores at 2 Months","Patient-reported impact of surgery on self-image and social interaction. Measured using FACE-Q Aesthetics scales: Psychological Function, Social Function, and Appearance-Related Distress. Raw scores are summed and converted (0-100). Imputation is applied when ≥50% of items are answered. Higher scores reflect better outcomes, except for Distress, where higher scores indicate worse distress.",{"measure":49,"description":50,"timeFrame":51},"Assessment of Early Symptom Recovery at 7 Days","Evaluates discomfort, swelling, and return to normal activities. Assessed with FACE-Q Aesthetics scales for \"Recovery Early Symptoms\" and \"Eyelids-upper.\" Scoring follows standard FACE-Q procedure with 0-100 conversion. Missing values are imputed if ≥50% of items are answered. Higher scores reflect better recovery and appraisal.","Day 7 (±1 day) after surgery",{"measure":53,"description":54,"timeFrame":55},"Satisfaction with Surgical Outcome and Decision at 2 Months","Includes willingness to undergo the procedure again. Evaluated using FACE-Q Aesthetics scales: \"Satisfaction with Outcome\" and \"Satisfaction with Decision.\" Scores range from 0 (worst) to 100 (best). Missing data is managed per FACE-Q guidelines: impute mean values if ≥50% of items are completed.","Month 2 (±1 week) after surgery",{"measure":57,"description":58,"timeFrame":59},"Incidence of Surgical Complications Using Clavien-Dindo Classification","Surgical complications recorded intraoperatively, and at 7 days, 2 and 6 months.","Day of surgery (Day 0), Day 7 (±1 day), Month 2 (±1 week), and Month 6 (±2 weeks) after surgery",{"measure":61,"description":62,"timeFrame":63},"Surgical Time Comparison","Total duration of the surgical procedure, defined as the time elapsed from the patient's entry into the operating room until their exit after completion of surgery, will be recorded and compared between each surgery group.","Day of surgery (Day 0); from operating room entry to exit (recorded in minutes)",null,{"allocation":66,"interventionModel":67,"interventionModelDescription":64,"primaryPurpose":68,"observationalModel":64,"timePerspective":64,"maskingInfo":69},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":70,"maskingDescription":64,"whoMasked":64},"NONE","This is a prospective, randomized, controlled clinical trial designed to compare the efficacy, functional outcomes, aesthetic results, and patient-reported satisfaction associated with two surgical techniques for correcting primary aponeurotic ptosis: anterior white line advancement and posterior white line advancement.\n\nParticipants will be randomized 1:1 into two parallel groups. In the anterior approach, access to the levator aponeurosis is achieved via a skin crease incision, and advancement is performed using sutures placed on the white line to reattach it to the anterior surface of the tarsus. In the posterior approach, access is gained through a conjunctival incision above the superior tarsal border, followed by dissection to expose the white line and suture advancement to the anterior tarsus, without a skin incision.\n\nFunctional eyelid position will be assessed through MRD1 measurements, symmetry evaluation, and contour analysis. Contour will be quantified objectively using ImageJ software with Bézier curve fitting, and subjectively through independent masked evaluations based on pre-defined criteria.\n\nPatient-reported outcomes will be assessed using the validated FACE-Q Aesthetics questionnaire, including scales for appearance satisfaction, psychosocial function, early recovery, and satisfaction with the surgical outcome and decision. Tear film stability and ocular surface parameters will be assessed using TBUT, Schirmer test (without anesthesia), and the Ocular Surface Disease Index (OSDI).\n\nStandardized digital photographs will be taken at each follow-up visit to ensure consistent evaluation of eyelid contour and aesthetic results. All images and clinical data will be securely stored with restricted access for authorized investigators only.\n\nFollow-up visits are scheduled for Day 7, Month 2, and Month 6 postoperatively. No masking will be applied due to the nature of the surgical techniques; however, outcome assessors for eyelid contour and patient-reported measures will remain blinded to group assignment.\n\nThis study aims to generate high-quality comparative data to guide clinical decision-making in the surgical management of aponeurotic ptosis, with an emphasis on both anatomical and patient-centered outcomes.",[73,79],{"label":74,"type":75,"description":76,"interventionNames":77},"Anterior Approach Group","EXPERIMENTAL","Participants will undergo upper eyelid ptosis correction using the anterior approach, involving a skin incision through the upper eyelid crease to access the levator aponeurosis",[78],"Procedure: Anterior White Line Advancement Surgery",{"label":80,"type":81,"description":82,"interventionNames":83},"Posterior Approach Group","ACTIVE_COMPARATOR","Participants will undergo upper eyelid ptosis correction using the posterior approach, which avoids skin incision and accesses the levator aponeurosis via the conjunctiva.",[84],"Procedure: Posterior White Line Advancement Surgery",[86,91],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":64},"PROCEDURE","Anterior White Line Advancement Surgery","This technique involves a skin incision at the eyelid crease, dissection through the orbicularis muscle to expose the tarsus, and proximal dissection in the pre-Müller-conjunctival plane to visualize the white line. A double-armed 5-0 absorbable suture is used to advance the white line to the anterior tarsal surface. Eyelid height and contour are assessed before final fixation. Skin closure is completed with a non-absorbable suture.",[74],{"type":87,"name":92,"description":93,"armGroupLabels":94,"otherNames":64},"Posterior White Line Advancement Surgery","This conjunctival technique uses a traction suture and eyelid eversion to access the posterior surface of the eyelid. A conjunctival incision is made above the superior tarsal border, followed by dissection to expose the white line. A double-armed 5-0 absorbable suture is passed through the anterior tarsus and the white line, and tied after confirming adequate eyelid position. The conjunctiva is not sutured.",[80],[96],{"name":97,"affiliation":98,"role":99},"Viviana Patricia Lezcano Carduz, MD","Rey Juan Carlos Hospital","PRINCIPAL_INVESTIGATOR",[101,105],{"name":97,"role":102,"phone":103,"phoneExt":64,"email":104},"CONTACT","+34 914816225","viviana.lezcano@quironsalud.es",{"name":106,"role":102,"phone":103,"phoneExt":64,"email":107},"Francisco Javier González García, MD, PhD","fjavier.gonzalez@hospitalreyjuancarlos.es",[109],{"facility":98,"status":110,"city":111,"state":112,"zip":113,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"RECRUITING","Móstoles","Madrid","28932","Spain","ES",{"type":117,"coordinates":118},"Point",[119,120],-3.86496,40.32234,{"lat":120,"lon":119},[123,126,128],{"name":124,"role":102,"phone":103,"phoneExt":64,"email":125},"Viviana Patricia Lezcano Carduz, Principal Investigator","viviana.lezcano@hospitalreyjuancarlos.es",{"name":127,"role":102,"phone":103,"phoneExt":64,"email":107},"Francisco Javier González García, Site Sub-Investigator",{"name":97,"role":99,"phone":64,"phoneExt":64,"email":64},{"type":99,"investigatorFullName":130,"investigatorTitle":131,"investigatorAffiliation":5,"oldNameTitle":64,"oldOrganization":64},"Viviana Patricia Lezcano Carduz","Principal Investigator.","100593197",false,"NCT07003308","Anterior Versus Posterior White Line Advancement Technique in the Correction of Aponeurotic Ptosis","Comparative Study of the Efficacy of Anterior Versus Posterior White Line Advancement Technique in the Correction of Primary Aponeurotic Ptosis","Inclusion Criteria:\n\n* Age over 18 years.\n* Diagnosis of primary aponeurotic upper eyelid ptosis.\n* Levator muscle function of 12 mm or greater.\n* Provision of written informed consent after receiving adequate information about the study.\n\nExclusion Criteria:\n\n* Diagnosis of non-aponeurotic eyelid ptosis.\n* Poor levator muscle function.\n* History of recurrent eyelid ptosis or previous eyelid ptosis surgery.\n* Medical or surgical history that, in the investigator's judgment, may interfere with participation.\n* Individuals with childbearing potential who are not using highly effective contraception methods.\n* Refusal to participate in the study or to sign the informed consent form.","ALL","18 Years",{"count":141,"type":142},54,"ESTIMATED","INTERVENTIONAL",[145],"NA","The goal of this clinical trial is to compare the efficacy of two surgical techniques-anterior and posterior white line advancement-for the correction of primary aponeurotic ptosis in adult patients. The main questions it aims to answer are:\n\nDoes the anterior approach lead to a greater improvement in Marginal Reflex Distance 1 (MRD1) at 6 months compared to the posterior approach?\n\nAre there differences in eyelid symmetry, contour, visual function, and patient satisfaction between the two techniques?\n\nResearchers will compare the anterior approach group to the posterior approach group to see if one offers better functional and aesthetic outcomes, fewer complications, or higher patient satisfaction.\n\nParticipants will:\n\nBe randomly assigned to receive either anterior or posterior white line advancement surgery.\n\nUndergo preoperative and postoperative evaluations at 7 days, 2 months, and 6 months, including:\n\nMeasurements of eyelid position (MRD1), contour, and symmetry\n\nVision and tear film tests (e.g., refraction, TBUT, Schirmer's test)\n\nSurveys on dry eye symptoms (OSDI), scar quality (POSAS 2.0), satisfaction, and psychosocial function\n\nMonitoring of surgical time and complications",[148],"Ptosis, Eyelid",[150,151,152,153,154],"eyelid","levator palpebrae","oculoplastic surgery","ophthalmology","blepharoptosis","2025-10-02",{"date":157,"type":158},"2025-10-07","ACTUAL",{"date":160,"type":158},"2025-06-01",{"date":162,"type":142},"2027-01-30",{"name":5,"class":6},1]