[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03504800":3,"trial-entities:NCT03504800":124,"trial-summary:NCT03504800":133},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":24,"primary_purpose":17,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":56,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":78,"locations":82,"central_contacts":115,"overall_officials":118,"references":122,"see_also_links":123},"NCT03504800","IRB#000018036","OCT in Diagnosis of Irregular Corneas","Optical Coherence Tomography-Aided Differential Diagnosis and Treatment of Irregular Corneas","RECRUITING","2031-02-28","2025-09","2025-09-09","2018-05-01","Oregon Health and Science University","OTHER",false,"This main goal of this study is to improve the detection, classification, monitoring, and treatment of irregular corneas due to keratoconus, warpage, dry eye, scar, stromal dystrophies, and other corneal conditions.\n\nThe primary goal will be achieved by using optical coherence tomography (OCT) to:\n\n1. Develop an OCT-based system to classify and evaluate corneal-shape irregularities.\n2. Develop OCT metrics for more sensitive detection of keratoconus progression.\n3. Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas.",null,[19,20,21],"Keratoconus","Corneal Opacity","Corneal Dystrophy",[23,19],"OCT","OBSERVATIONAL",[],{"count":27,"type":28},445,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Optical Coherence Tomography","This device will be used to tightly classify corneal irregularities and determine eligibility of candidates from Group A into Groups B \\& C.",[35,36,37],"Group A: Classification of Corneal Irregularities","Group B: Detection of Keratoconus Progression","Group C: OCT-and-Topography Guided PTK",[39,43,45,49,50,54],{"measure":40,"description":41,"timeFrame":42},"Develop OCT-based system to classify and evaluate corneal-shape irregularities","Clinical classification of keratoconus, epithelial deformation, stromal addition\u002Fsubtraction, stromal distortion, and healthy controls by OCT. Primary measurements will be corneal and epithelial thicknesses assessed in micron units.","1 day",{"measure":40,"description":44,"timeFrame":42},"Secondary measurement will be OCT corneal shape assessed in Diopter units.",{"measure":46,"description":47,"timeFrame":48},"Develop OCT metrics for more sensitive detection of keratoconus progression","Primary measurements will be OCT corneal and epithelial thicknesses assessed in micron units.","4 year",{"measure":46,"description":44,"timeFrame":48},{"measure":51,"description":52,"timeFrame":53},"Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas","The primary goal is to improve the post-procedural outcome of uncorrected and best corrected visual acuity. This will be measured in feet by conventional Snellen fraction of 20\u002Fxx.","1 year",{"measure":51,"description":55,"timeFrame":53},"The secondary goal is to improve the post-procedural outcome of refractive error. This will be measured in Diopter units.",[],"ALL","14 Years","85 Years",true,{"inclusion":62,"exclusion":70,"raw_text":77},[63,64,65,66,67,68,69],"Keratoconus:","Contact lens-related corneal warpage:","Dry eye:","Epithelial basement membrane dystrophy (EBMD):","Stromal addition or subtraction:","Stromal distortion:","Normal controls:",[71,72,73,74,75,76],"Inability to give informed consent.","Inability to maintain fixation for OCT imaging.","Inability to commit to required study visits.","Eyes with concurrent cataract, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery.","Previous corneal surgeries if considered as a keratoconus participant.","Pregnancy or breastfeeding.","Inclusion Criteria:\n\nGROUP A:\n\n* Keratoconus:\n\n  1. CDVA ≥ 20\u002F25 in the better eye; and both of the following in the worse eye\n  2. Topography characteristic of keratoconus or pellucid marginal degeneration\n* Contact lens-related corneal warpage:\n\n  1. Contact lens use; and\n  2. Topography irregularities\n* Dry eye:\n\n  1. Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and\n  2. Topography irregularities\n  3. Presence of punctate epithelial erosion on exam with surface staining\n  4. Aqueous deficiency or evaporative dry eye\n* Epithelial basement membrane dystrophy (EBMD):\n\n  1. Negative corneal fluorescein staining; and\n  2. Corneal opacities; and\n  3. Topography irregularities\n* Stromal addition or subtraction:\n\n  1. Scars; or\n  2. Salzmann's degeneration; or\n  3. Stromal dystrophies; or\n  4. Complication (visual complaints) after LASIK or photorefractive keratectomy (PRK)\n* Stromal distortion:\n\n  1. Radial keratectomy (RK); or\n  2. Corneal transplants.\n* Normal controls:\n\n  1. Healthy eyes with no previous eye procedures\u002Fsurgeries.\n\nGROUP B:\n\nParticipants will be selected from the keratoconus population in Group A based on topography findings.\n\nGROUP C:\n\nParticipants will be selected from the stromal addition\u002Fsubtraction and stromal distortion populations of Group A if they have vision primarily limited by scars, dystrophy, or high astigmatism that could benefit from PTK.\n\nExclusion Criteria (all groups):\n\n* Inability to give informed consent.\n* Inability to maintain fixation for OCT imaging.\n* Inability to commit to required study visits.\n* Eyes with concurrent cataract, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery.\n* Previous corneal surgeries if considered as a keratoconus participant.\n* Pregnancy or breastfeeding.",[79,80,81],"CHILD","ADULT","OLDER_ADULT",[83],{"facility":84,"status":8,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":112},"Humberto Martinez","Portland","Oregon","97239","United States",[90,95,99,102,104,106,108,110],{"name":91,"role":92,"phone":93,"email":94},"Humberto Martinez, COT","CONTACT","503-494-7712","martinhu@ohsu.edu",{"name":96,"role":92,"phone":97,"email":98},"Denny Romfh, OD","503-494-4351","romfhd@ohsu.edu",{"name":100,"role":101},"David Huang, MD, PhD","SUB_INVESTIGATOR",{"name":103,"role":101},"Winston Chamberlain, MD, PhD",{"name":105,"role":101},"Richard Stutzman, MD",{"name":107,"role":101},"Afshan Nanji, MD",{"name":109,"role":101},"Ellen Davis, MD",{"name":111,"role":101},"Seema Gupta, MD",{"lat":113,"lon":114},45.52345,-122.67621,[116,117],{"name":91,"role":92,"phone":93,"email":94},{"name":96,"role":92,"phone":97,"email":98},[119],{"name":120,"affiliation":13,"role":121},"Yan Li, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":125,"biomarkers":132},[126,21,127,128,129,130,19,131],"Astigmatism","Corneal opacity","Corneal Warpage","Dry eyes","Epithelial basement membrane dystrophy","Salzmann degeneration",[],{"nct_id":4,"found":60,"summary":134,"prompt_version":144},{"design":135,"status":136,"heading":137,"summary":138,"follow_up":139,"word_count":140,"commitments":141,"compensation":142,"drugs_mentioned":143},"This is an observational study planning to include 445 participants. It uses the Optical Coherence Tomography (OCT) device to classify corneal irregularities.","completed","Observational Study on OCT for Irregular Corneas","This study aims to improve how doctors detect, classify, monitor, and treat irregular corneas, which are problems with the clear front part of your eye. This includes conditions like keratoconus (a thinning of the cornea), corneal warpage from contact lenses, and dry eye. Researchers will use a device called Optical Coherence Tomography (OCT) to better understand these conditions. The main goals are to develop a system using OCT to classify corneal irregularities, find better ways to track the progression of keratoconus, and improve a laser treatment called phototherapeutic keratectomy (PTK) for irregular corneas. You might be able to join if you are between 14 and 85 years old and have certain eye conditions like keratoconus or contact lens-related corneal warpage.","The study aims to develop tools for detecting keratoconus progression over 4 years.",120,"Not specified in the trial record.","Not stated in the trial record.",[32],"v2"]