[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100380391":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":36,"centralContacts":41,"locations":52,"responsibleParty":83,"collaborators":85,"id":88,"slug":23,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":23,"eligibilityCriteria":92,"healthyVolunteers":89,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":23,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":55,"whyStopped":23,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Centre hospitalier de l'Université de Montréal (CHUM)","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"MicroPulse Treatment","EXPERIMENTAL","Prophylactic transscleral cyclophotocoagulation treatment, delivered by micropulse waves will be given 4-8 weeks before the Boston keratoprosthesis surgery.",[13],"Procedure: Transscleral cyclphophotocoagulation using the Micropulse system ( IRIDEX IQ810 Laser systems, Mountain View, CA).",{"label":15,"type":10,"description":16,"interventionNames":17},"G-Probe Treatment","Prophylactic transscleral cyclophotocoagulation treatment, delivered with a diode laser using the G-Probe device, will be given 4-8 weeks before the Boston keratoprosthesis surgery.",[18],"Procedure: G-Probe transscleral cyclphophotocoagulation (Iris Medical Instruments, Montain View, CA)",{"label":20,"type":21,"description":22,"interventionNames":23},"Historical Cohort","NO_INTERVENTION","An historical cohort composed of patients who received a Boston keratoprosthesis between january 2017 and january 2019 will be included. Only patients who did not receive any glaucoma treatment 3 months before their surgery will be included. A total of 10 patients will be selected with the goal of matching the preoperative characteristics of the interventional patients.\n\nThis group will serve as the control group in our study. Retrospective chart review will be performed for this branch.",null,[25,32],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"PROCEDURE","Transscleral cyclphophotocoagulation using the Micropulse system ( IRIDEX IQ810 Laser systems, Mountain View, CA).","Treatment will be applied over the limbal area to treat the ciliary body. The treatment will be delivered with an energy of 2000mW, a cycle of 31,33% and an on\u002Foff time of 0,5ms and 1,1ms. It will be delivered around a 360° surface with avoidance of the 3 and 9 o'clock areas. The treatment will be delivered during 80 secondes in each hemisphere and will be repeated twice, for a total of 320 secondes.",[9],[31],"MP-TSCPC",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"G-Probe transscleral cyclphophotocoagulation (Iris Medical Instruments, Montain View, CA)","Treatment will be applied over the limbal area to treat the ciliary body. Sixteen (16) shots in total, which is four (4) shorts per quadrants, will be transmitted with a power from 1750 to 2000mV (titrating according to an audible \"pop\") for a length of 2,0 secondes per shots. Treatment will be delivered around a 360° surface and avoiding the 3 and 9 o'clock areas.",[15],[37],{"name":38,"affiliation":39,"role":40},"Marie-Claude Robert, MD, MSc","Ophthalmology Department, Centre Hospitalier de l'Université de Montreal","PRINCIPAL_INVESTIGATOR",[42,48],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Marie-Catherine Thessier, MSc","CONTACT","514 890-8000","11550","marie-catherine.tessier.chum@ssss.gouv.qc.ca",{"name":49,"role":44,"phone":50,"phoneExt":23,"email":51},"Soumaya Bouhout, MD","5142640436","soumaya.bouhout@umontreal.ca",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Centre Hospitalier de l'Université de Montréal (CHUM)","RECRUITING","Montreal","Quebec","H2X 3E4","Canada",{"type":61,"coordinates":62},"Point",[63,64],-73.58781,45.50884,{"lat":64,"lon":63},[67,70,71,74,76,78,80,82],{"name":68,"role":44,"phone":69,"phoneExt":46,"email":47},"Marie-Catherine Thessier, Msc","514-890-8000",{"name":49,"role":44,"phone":50,"phoneExt":23,"email":51},{"name":72,"role":73,"phone":23,"phoneExt":23,"email":23},"Mona Harissi-Dagher, MD","SUB_INVESTIGATOR",{"name":75,"role":73,"phone":23,"phoneExt":23,"email":23},"Younes Agoumi, MD",{"name":77,"role":73,"phone":23,"phoneExt":23,"email":23},"Harmanjit Singh, MD",{"name":79,"role":73,"phone":23,"phoneExt":23,"email":23},"George Durr, MD",{"name":81,"role":73,"phone":23,"phoneExt":23,"email":23},"Qianqian Wang, MD",{"name":49,"role":73,"phone":23,"phoneExt":23,"email":23},{"type":84,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[86],{"name":87,"class":6},"Fonds de recherche en ophtalmologie de l'Université de Montréal","100380391",false,"NCT04232982","The Role of Transscleral Cyclophotocoagulation in Patients Undergoing a Boston Keratoprosthesis","Inclusion Criteria:\n\n* Adults patients\n* Able to give an informed consent\n* Capable of being followed during the study\n* Candidate for the Boston keratoprosthesis type I\n\nExclusion Criteria:\n\n* Patients younger than 18 years old or older than 80 years old\n* Unable to give an informed consent\n* Participating to another interventional glaucoma study\n* Patients who received a glaucoma surgery or procedure (glaucoma drainage device or TS-CPC treatment) 3 months before their initial visit.\n* Unable to wear a therapeutic contact lens secondary to eyelid malformation\n* Severe Ocular surface Disease with keratinization\n* Intra-ocular tumor\n* Terminal Glaucoma\n* Phthisis bulbi\n* Ocular albinism","ALL","18 Years","80 Years",{"count":97,"type":98},20,"ESTIMATED","INTERVENTIONAL",[101],"NA","The Boston keratoprosthesis (KPro) is a special plastic device that is used to replace a sick cornea (transparent part of the eye, in front of the iris) in order to restore vision in patients who have failed traditional corneal transplants or have a very poor prognosis of success.\n\nGlaucoma is a chronic disease which causes optic nerve damage secondary to high pressure inside the eye and could lead to vision loss in the long term. Glaucoma is highly prevalent in patients who require a KPro and even more after their procedure.\n\nIn order to decrease the intra-ocular pressure, surgeons can use multiple eyedrops. Unfortunately, following the KPro surgery, eyedrops lose their efficiency because they are less absorbed by the eye.\n\nThe transscleral cyclophotocoagulation (TS-CPC) is a laser treatment used in advanced refractory glaucoma. This laser helps decrease the intra-ocular pressure and have a better control of the disease. There are different methods of laser transmission, including the continuous transmission (G-Probe) and the micro-pulsation method (Micopulse). Given the high prevalence of glaucoma in patients receiving a KPro, the investigators are studying the effect of giving the TS-CPC treatment prophylactically to patients before their Boston keratoprosthesis.\n\nOur hypothesis is that prophylactic TS-CPC will decrease glaucoma progression as well as the risks of developing glaucoma following the Boston keratoprosthesis .\n\nMETHOD The investigators aim to recruit twenty (20) patients who are scheduled to receive Boston KPro. Participants will be randomized into two groups: 1) Groupe 1 will receive a prophylactic treatment of transscleral cyclophotocoagulation a G-Probe. 2) Groupe 2 will receive a prophylactic treatment of transscleral cyclophotocoagulation with a micropulse transmission (MicroPulse). The patients will receive their laser treatment by a glaucoma specialist 4 to 8 weeks before their KPro surgery. One week following their laser treatment, the participants will be examined by their glaucoma specialist.\n\nFollowing their KPro surgery, patients will have a follow-up at day-1, weeks 1 and 2, months 1 and 3, then every 4 to 6 months for 5 years. Additional non-invasive glaucoma tests will be performed twice during the first 3 months following the surgery and will be repeated every 4-6 months. Visual acuity results, the visual field tests and rates of post-operative complications will be compared between the different groups.",[104,105,106],"Glaucoma","Eye Diseases","Cornea Disease",[108,109,110,111],"Boston keratoprosthesis","Transscleral cyclophotocoagulation","Micropulse transscleral cyclophotocoagulation","G-Probe Transscleral cyclophotocoagulation","2026-04-23",{"date":114,"type":115},"2026-04-27","ACTUAL",{"date":117,"type":115},"2020-01-30",{"date":119,"type":98},"2036-12-01",{"name":5,"class":6},1]