[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05924477":3,"trial-entities:NCT05924477":192,"trial-summary:NCT05924477":195},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":42,"secondary_outcomes":47,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":82,"locations":85,"central_contacts":174,"overall_officials":179,"references":190,"see_also_links":191},"NCT05924477","853474","Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial","RECRUITING","2027-12","2026-07","2026-07-14","2023-07-11","University of Pennsylvania","OTHER",true,"Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE) is a multi-center, outcome-masked, randomized clinical trial. The purpose of this study is to compare glaucoma drainage device implantation in the anterior chamber (front part of the eye) and sulcus (small space between iris and front chamber of the eye) in efforts to minimize cell loss in the eye.","The DECLARE Trial is a prospective 1:1 randomized, parallel design, double-masked clinical trial to compare endothelial cell density (ECD), intraocular pressure (IOP) and metagenomic RNA deep sequencing (MDS) between sulcus and anterior chamber (AC) tube placement after glaucoma drainage device (GDD) implantation.\n\nThe trial has fixed sample size with 12 months follow-up for primary outcome assessment and trial participants will continue to be followed to the end of grant cycle with a total of 24 months follow-up.\n\nPatients will be randomized to 2 tube locations for GDD implantation:\n\n* Tube placed in the AC\n* Tube placed in ciliary sulcus\n* Stratification: by clinical center and type of surgery (GDD alone vs GDD combined with phacoemulsification). Stratified randomization by clinical center is to ensure that a similar number of subjects will be randomized to either sulcus tube or AC tube placement for a specific clinical center. Because eyes undergoing a combined phacoemulsification with GDD implantation may be associate with larger ECL from phacoemulsification, stratified by surgery type is to ensure two tube location groups similar number of study eyes that will undergo a combined phacoemulsification with GDD implantation.",[18],"Glaucoma",[20,21,22,23,24],"glaucoma","glaucoma drainage device","endothelial cell density","endothelial cell loss","intraocular pressure","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},226,"ESTIMATED",[33,38],{"type":34,"name":35,"description":36,"armGroupLabels":37},"PROCEDURE","Sulcus tube placement","GDD implantation surgery with tube placement in the ciliary sulcus",[35],{"type":34,"name":39,"description":40,"armGroupLabels":41},"Anterior chamber (AC) tube placement","GDD implantation surgery with tube placement in the anterior chamber",[39],[43],{"measure":44,"description":45,"timeFrame":46},"Central endothelial cell loss (ECL) from baseline","Change in central endothelial cell density based on assessment of Specular Microscopy images.","Baseline to 12 months",[48,52,55,58],{"measure":49,"description":50,"timeFrame":51},"Intraocular Pressure (IOP) at 12 months","Goldman applanation tonometry (preferred method)","12 months after GDD implantation",{"measure":53,"description":54,"timeFrame":51},"ECD at 12 months after GDD implantation","ECD measures will be based on the assessment of Specular Microscopy images",{"measure":56,"description":57,"timeFrame":51},"Best-corrected visual acuity (BCVA) at 12 months after GDD implantation","Distance BCVA using an ETDRS eye chart and recorded as number of letters read correctly.",{"measure":59,"description":60,"timeFrame":51},"Number of anti-glaucoma medications at 12 months after GDD implantation","Topical and oral anti-glaucoma medication information is collected at all visits.","ALL","18 Years",null,false,{"inclusion":66,"exclusion":70,"raw_text":81},[67,68,69],"Medically uncontrolled glaucoma requiring GDD or GDD combined with phacoemulsification as the planned surgical procedure","Candidate for GDD implantation for ciliary sulcus and AC tube","Age greater than or equal to 18 years old",[71,72,73,74,75,76,77,78,79,80],"Preexisting corneal condition that would affect the corneal endothelium or previous corneal transplant","Presence or history of Cypass Micro-Stent","Previous GDD, Xen Gel Stent or Preserflo MicroShunt removed less than 6 months before surgery","Presence of GDD implantation, Xen Gel Stent, of Preserflo MicroShunt","Previous trabeculectomy and\u002For minimally invasive glaucoma surgery within the past 6 months","AC intraocular lens","Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure","Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits","No light perception vision in the study eye or fellow eye visual acuity \\\u003C 20\u002F200","Need for glaucoma surgery combined with other ocular procedures (i.e. corneal transplant, or retinal surgery) or anticipated need for additional ocular surgery","Inclusion Criteria:\n\n* Medically uncontrolled glaucoma requiring GDD or GDD combined with phacoemulsification as the planned surgical procedure\n* Candidate for GDD implantation for ciliary sulcus and AC tube\n* Age greater than or equal to 18 years old\n\nExclusion Criteria:\n\n* Preexisting corneal condition that would affect the corneal endothelium or previous corneal transplant\n* Presence or history of Cypass Micro-Stent\n* Previous GDD, Xen Gel Stent or Preserflo MicroShunt removed less than 6 months before surgery\n* Presence of GDD implantation, Xen Gel Stent, of Preserflo MicroShunt\n* Previous trabeculectomy and\u002For minimally invasive glaucoma surgery within the past 6 months\n* AC intraocular lens\n* Presence of nanophthalmos, uncontrolled uveitis, silicone oil, Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure\n* Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits\n* No light perception vision in the study eye or fellow eye visual acuity \\\u003C 20\u002F200\n* Need for glaucoma surgery combined with other ocular procedures (i.e. corneal transplant, or retinal surgery) or anticipated need for additional ocular surgery",[83,84],"ADULT","OLDER_ADULT",[86,99,109,120,131,142,153,164],{"facility":87,"status":7,"city":88,"state":89,"zip":90,"country":91,"contacts":92,"geoPoint":96},"University of California San Francisco","San Francisco","California","94143","United States",[93],{"name":94,"role":95},"Ying Han, MD, PhD","CONTACT",{"lat":97,"lon":98},37.77493,-122.41942,{"facility":100,"status":7,"city":101,"state":89,"zip":102,"country":91,"contacts":103,"geoPoint":106},"Diablo Eye Associates","Walnut Creek","94598",[104],{"name":105,"role":95},"Yen Cheng Hsia, MD",{"lat":107,"lon":108},37.90631,-122.06496,{"facility":110,"status":7,"city":111,"state":112,"zip":113,"country":91,"contacts":114,"geoPoint":117},"Bascom Palmer Eye Institute","Miami","Florida","33136",[115],{"name":116,"role":95},"Steven Gedde, MD",{"lat":118,"lon":119},25.77427,-80.19366,{"facility":121,"status":7,"city":122,"state":123,"zip":124,"country":91,"contacts":125,"geoPoint":128},"Wilmer Eye Institute, Johns Hopkins University","Baltimore","Maryland","21287",[126],{"name":127,"role":95},"Pradeep Yammanuru Ramulu, MD, PhD",{"lat":129,"lon":130},39.29038,-76.61219,{"facility":132,"status":7,"city":133,"state":134,"zip":135,"country":91,"contacts":136,"geoPoint":139},"Massachusetts Eye and Ear","Boston","Massachusetts","02114",[137],{"name":138,"role":95},"Teresa Chen, MD",{"lat":140,"lon":141},42.35843,-71.05977,{"facility":143,"status":7,"city":144,"state":145,"zip":146,"country":91,"contacts":147,"geoPoint":150},"University of Buffalo\u002FState University of New York","Buffalo","New York","14203",[148],{"name":149,"role":95},"Sandra Sieminski, MD",{"lat":151,"lon":152},42.88645,-78.87837,{"facility":154,"status":7,"city":155,"state":156,"zip":157,"country":91,"contacts":158,"geoPoint":161},"University of North Carolina at Chapel Hill","Chapel Hill","North Carolina","27517",[159],{"name":160,"role":95},"Rodolfo Bonatti, MD",{"lat":162,"lon":163},35.9132,-79.05584,{"facility":165,"status":7,"city":166,"country":167,"contacts":168,"geoPoint":171},"Prism Eye Institute, University of Toronto","Toronto","Canada",[169],{"name":170,"role":95},"Iqbal Ike Ahmed, MD, PhD",{"lat":172,"lon":173},43.70643,-79.39864,[175],{"name":176,"role":95,"phone":177,"email":178},"Gui-shuang Ying, PhD","215-615-1514","gsying@pennmedicine.upenn.edu",[180,183,187],{"name":94,"affiliation":181,"role":182},"University of California, San Francisco","STUDY_CHAIR",{"name":184,"affiliation":185,"role":186},"Jennifer Rose-Nussbaumer, MD","Stanford University","STUDY_DIRECTOR",{"name":188,"affiliation":189,"role":186},"Thuy Doan, MD, PhD","University of California San Fransicso",[],[],{"nct_id":4,"conditions":193,"biomarkers":194},[18],[],{"nct_id":4,"found":14,"summary":196,"prompt_version":204},{"design":197,"status":198,"heading":6,"summary":199,"follow_up":197,"word_count":200,"commitments":201,"compensation":202,"drugs_mentioned":203},"Not specified.","completed","{\n   \"Glaucoma Drainage Device and Endothelial Cell Loss Compare Trial (DECLARE)\",\n   \"This study, called DECLARE, is comparing two ways to place a glaucoma drainage device (GDD) during surgery for medically uncontrolled glaucoma. You might be able to join if you are at least 18 years old and need a GDD, or a GDD combined with cataract surgery (phacoemulsification). Researchers want to see if placing the GDD tube in the anterior chamber (front part of the eye) or the ciliary sulcus (a small space between the iris and the front chamber of the eye) leads to less central endothelial cell loss (ECL) in your eye. This cell loss is measured over 12 months. The study is looking for 226 participants, but its current status is unclear.\",\n  \"design\": \"This is a randomized study, meaning you would be assigned by chance to one of two groups. It is also \\\"double-masked,\\\" so neither you nor your doctors will know which tube placement you receive.\",\n  \"commitments\": \"You would undergo GDD implantation surgery with either sulcus tube placement or anterior chamber tube placement. You will be followed for 12 months for the main outcome, and then for a total of 24 months.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be followed for 12 months for the primary outcome, and then for a total of 24 months.\",\n}",224,"Not specified in the trial record.","Not stated in the trial record.",[35],"v2"]