[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624092":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":59,"studyPopulation":53,"armGroups":60,"interventions":73,"overallOfficials":83,"centralContacts":91,"locations":97,"responsibleParty":132,"collaborators":53,"id":134,"slug":53,"hasResults":135,"nctId":136,"briefTitle":137,"officialTitle":137,"acronym":53,"eligibilityCriteria":138,"healthyVolunteers":135,"sex":139,"minAge":140,"maxAge":53,"enrollmentInfo":141,"targetDuration":53,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":53,"overallStatus":150,"whyStopped":53,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Lumenis Be Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":21},[9],{"measure":10,"description":11,"timeFrame":12},"The percentage of resolved chalazion 4 weeks after the last treatment in the study group and the control group","the proportion of subjects with reduction of at lease 80% in lesion size at the follow up visit","4 weeks after the last treatment",[14,17],{"measure":15,"description":16,"timeFrame":12},"Percentage change from baseline in lesion size in both groups","measuring the lesion size using a millimeter caliper",{"measure":18,"description":19,"timeFrame":20},"Time to resolution which is defined as a reduction of at least 80% in lesion size in both groups","measuring the time that takes for a reduction of at least 80% in lesion size","4 weeks after last treatment",[22,25,28,31,35,38,41,44],{"measure":23,"description":24,"timeFrame":12},"modified Meibomian Gland Score","15 Meibomian glands along the lower lid (5 nasal + 5 central + 5 temporal) will be gently expressed with the dedicated expression forceps. Each gland will be scored 0 to 3, as follows: 0 = clear liquid meibum; 1 = cloudy liquid meibum; 2\n\n= inspissated meibum; 3 = blocked). The modified Meibomian Gland score will be evaluated as the sum of scores for these 15 glands. Hence, the minimal value is 0 (all 15 glands express a clear liquid meibum), and the maximal value is 45 (all 15 glands are blocked). A decrease in the modified Meibomian Gland Score means that the functionality of Meibomian glands improved, and that the condition of the patient improved.",{"measure":26,"description":27,"timeFrame":12},"Teat Breakup time","Time between full blink and first appearance of a break in a fluorescein-stained eye",{"measure":29,"description":30,"timeFrame":12},"BCVA","Best-corrected visual acuity, using an ETDRS chart (20\u002F20, 20\u002F25, 20\u002F32,20\u002F40,20\u002F50,20\u002F63, 20\u002F80, 20\u002F100, 20\u002F200, 20\u002F400, where 20\u002F20 is considered perfect vision and 20\u002F400 is considered legal blindness)",{"measure":32,"description":33,"timeFrame":34},"Adverse events","Incidence and type of adverse events","up to 7 weeks",{"measure":36,"description":37,"timeFrame":12},"IOP","intra ocular pressure using tonometer",{"measure":39,"description":40,"timeFrame":12},"Biomicroscopy","Eyelid appearance will be assessed with biomicroscopy at the slit lamp",{"measure":42,"description":43,"timeFrame":12},"satisfaction level","subject will fill out a satisfaction questionnaire (very satisfied\u002Fsatisfied\u002Fneutral\u002Fdisappointed\u002Fvery disappointed).",{"measure":45,"description":46,"timeFrame":47},"Pain\u002FDiscomfort","Pain\u002Fdiscomfort will be self-reported with a visual analog scale (0 to 10), with 0 representing no pain\u002Fdiscomfort and 10 representing intolerable pain\u002Fdiscomfort.","immediately after the treatment",{"allocation":49,"interventionModel":50,"interventionModelDescription":51,"primaryPurpose":52,"observationalModel":53,"timePerspective":53,"maskingInfo":54},"RANDOMIZED","PARALLEL","randomized, double masked, controlled study","TREATMENT",null,{"masking":55,"maskingDescription":53,"whoMasked":56},"DOUBLE",[57,58],"PARTICIPANT","OUTCOMES_ASSESSOR","The study aims to evaluate the effectiveness and safety of IPL therapy for the treatment of chalazion. The effect of IPL on chalazion will be examined in a masked randomized controlled study. Subjects in the study arm will be treated with IPL, while subjects in the control arm will be treated with sham IPL. A significant difference in the outcomes of the two arms will provide support for a genuine contribution of the IPL treatment",[61,67],{"label":62,"type":63,"description":64,"interventionNames":65},"study arm","EXPERIMENTAL","subjects in the study arm will receive active IPL treatment",[66],"Device: Active IPL",{"label":68,"type":69,"description":70,"interventionNames":71},"Control arm","SHAM_COMPARATOR","subjects in the control arm will receive sham IPL treatment",[72],"Device: Sham IPL",[74,79],{"type":75,"name":76,"description":77,"armGroupLabels":78,"otherNames":53},"DEVICE","Sham IPL","Three sham IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment",[68],{"type":75,"name":80,"description":81,"armGroupLabels":82,"otherNames":53},"Active IPL","Three active IPL treatments in 1-week interval followed by 1 follow-up 4 weeks after the last treatment",[62],[84,88],{"name":85,"affiliation":86,"role":87},"James Chelnis, MD","Manhattan Face and Eye clinic","PRINCIPAL_INVESTIGATOR",{"name":89,"affiliation":90,"role":87},"Laura Periman","Periman Eye Institute",[92],{"name":93,"role":94,"phone":95,"phoneExt":53,"email":96},"Haya Hamza, Bsc","CONTACT","+972527493696","haya.hamza@lumenis.com",[98,113],{"facility":86,"status":53,"city":99,"state":99,"zip":100,"country":101,"countryCode":102,"cosmosGeoPoint":103,"geoPoint":108,"contacts":109},"New York","10019","United States","US",{"type":104,"coordinates":105},"Point",[106,107],-74.00597,40.71427,{"lat":107,"lon":106},[110,112],{"name":85,"role":94,"phone":53,"phoneExt":53,"email":111},"drchelnis@manhattanfaceandeye.com",{"name":85,"role":87,"phone":53,"phoneExt":53,"email":53},{"facility":90,"status":53,"city":114,"state":115,"zip":116,"country":101,"countryCode":102,"cosmosGeoPoint":117,"geoPoint":121,"contacts":122},"Seattle","Washington","98119",{"type":104,"coordinates":118},[119,120],-122.33207,47.60621,{"lat":120,"lon":119},[123,127,131],{"name":124,"role":94,"phone":125,"phoneExt":53,"email":126},"Laura Periman, MD","206-347-0821","ClinicalTrials@perimaneyeinstitute.com",{"name":128,"role":94,"phone":129,"phoneExt":53,"email":130},"AnaLucia Clarkson","+1 (206) 3470821","concierge@perimaneyeinstitute.com",{"name":124,"role":87,"phone":53,"phoneExt":53,"email":53},{"type":133,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR","100624092",false,"NCT07405138","Evaluation of Effectiveness and Safety of Intense Pulsed Light Treatment for Chalazion","Inclusion Criteria:\n\n* Subject is able to read, understand, and sign an Informed Consent Form (ICF)\n* 18 years of age or older\n* Clinical diagnosis of chalazion in the inflammatory stage\n* Subject is willing to comply with all study procedures-\n\nExclusion Criteria:\n\n* Concurrent eyelid infection\n* Chalazion with atypical features, which to the opinion of the study investigator is inadequate for a study\n* Recurring Chalazion\n* Floppy eyelid syndrome\n* Demodex blepharitis patients taking Lotilaner ophthalmic solution within 30 days prior to screening\n* Ocular surgery within 3 months prior to screening\n* Current diagnosis of malignant tumors in the affected eyelid, including:\n\nsebaceous carcinoma and basal cell carcinoma\n\n* Laser Assisted In Situ Keratomileusis (LASIK)\u002FSmall Incision Lenticule Extraction (SMILE) surgery, within 1 year prior to screening\n* Radial Keratotomy (RK) surgery\n* Recent ocular trauma, within 3 months prior to screening\n* Pre-cancerous lesions or skin cancer in the planned treatment area\n* Severe active allergies, or other severe uncontrolled eye disorders affecting the ocular surface\n* Uncontrolled infections or uncontrolled immunosuppressive diseases\n* Best corrected visual acuity worse than 20\u002F200 in either eye\n* Ocular surface abnormality that may compromise corneal integrity in either eye (e.g., prior chemical burn, Epithelial Basement Membrane Dystrophy - EBMD)\n* Within 1 week prior to screening, use of photosensitive medication and\u002For herbs that may cause sensitivity to 560-1200 nm light exposure, including: Isotretinoin, Tetracycline, Doxycycline, and St. John's Wort\n* Active sun burn in the treatment area\n* Anterior chamber inflammation\n* Corneal edema\n* Any condition revealed w","ALL","18 Years",{"count":142,"type":143},40,"ESTIMATED","INTERVENTIONAL",[146],"NA","To study the effectiveness and safety of IPL treatment for Chalazion",[149],"Chalazion","NOT_YET_RECRUITING","2026-02-17",{"date":153,"type":154},"2026-02-19","ACTUAL",{"date":156,"type":143},"2026-02-04",{"date":158,"type":143},"2026-12",{"name":5,"class":6},2]