[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"glaucoma-1-open-angle-d-disorder\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:glaucoma-1-open-angle-d-disorder":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100620586","comparing-xen-63-gel-stent-and-preserflo-microshunt-100620586",false,"NCT07359547","Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt","Minimally Invasive Bleb-Forming Surgical Approaches for Treating Primary Open-Angle Glaucoma: A Randomized Controlled Trial Comparing XEN®-63 Gel Stent and PRESERFLO® MicroShunt","MINI-BATTLE","Inclusion Criteria:\n\n* \\>40 years of age\n* An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEX)\n* Inadequately controlled on maximum tolerated medical therapy.\n* Mean Deviation (MD) \\\u003C\u002F= -3\n* Intraocular pressure of 14-28 mmHg\n* Endothelial Cell Count ≥1000 cells\u002Fmm2\n\nExclusion Criteria:\n\n* An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX)\n* Lens status: Aphakic patients or Anterior chamber intraocular lens\n* Previous procedures: Glaucoma shunt\u002Fvalve\u002F surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months.\n* Presence of intraocular silicone oil\n* No light perception vision\n* Current corticosteroid use (ocular or oral)\n* Conjunctival pathologies (e.g., pterygium)\n* Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)\n* Vitreous present in the anterior chamber\n* Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date\n* Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits","ALL","40 Years",{"count":20,"type":21},166,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this randomized controlled clinical trial is to learn whether two minimally invasive bleb-forming glaucoma implants can effectively treat adult patients with open-angle glaucoma who require surgical lowering of intraocular pressure (IOP). Specifically, the study evaluates whether the PRESERFLO™ MicroShunt is at least as effective as the XEN®-63 Gel Stent in reducing IOP after surgery. \n\nThe main questions it aims to answer are:\n\n* Does the PRESERFLO™ MicroShunt provide IOP reduction at 12 months that is non-inferior to the XEN®-63 Gel Stent?\n* How do the two devices compare over 24 months with respect to medication reduction, need for additional glaucoma procedures, complications, and preservation of visual function and ocular structures?\n\nParticipants will:\n\n* Be randomly assigned (1:1) to receive either the XEN®-63 Gel Stent or the PRESERFLO™ MicroShunt during a single glaucoma surgery.\n* Attend scheduled follow-up visits over 24 months for eye-pressure measurements, vision testing, visual-field testing, OCT imaging, endothelial-cell counts, and safety assessments.\n* Receive standard postoperative care and report any complications or additional treatments during the study period.",[27],"GLAUCOMA 1, OPEN ANGLE, D (Disorder)",[29,30,31,32,33,34,35,36,37],"Glaucoma","MIBS","Minimally Invasive Bleb-Forming Surgery","Bleb-Forming Devices Without a Plate","Surgery","PRESERFLO","MicroShunt","XEN","Gelstent","RECRUITING","2026-04-28",{"date":41,"type":42},"2026-04-29","ACTUAL",{"date":44,"type":42},"2026-01-01",{"date":46,"type":21},"2028-01",{"name":48,"class":49},"Universitaire Ziekenhuizen KU Leuven","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100631152","preserflo-microshunt-versus-trabeculectomy-100631152","NCT07496957","Preserflo MicroShunt Versus Trabeculectomy","Preserflo MicroShunt Implantation Versus Trabeculectomy in Managing Open-Angle Glaucoma","PMSvT","Inclusion Criteria:\n\n-\\>21 years of age\n\n* An established diagnosis of: Primary open angle glaucoma, Normal tension glaucoma, Pigment dispersion glaucoma (PDG) or Pseudoexfoliative glaucoma (PEXG)\n* Inadequately controlled on maximum tolerated medical therapy\n* Mean Deviation (MD) \\\u003C\u002F= -3\n* Intraocular pressure of 14-28 mmHg\n* Endothelial Cell Count ≥1000 cells\u002Fmm2\n\nExclusion Criteria:\n\n* An established diagnosis of: Closed-angle glaucoma or Secondary open-angle glaucoma (besides PDG and PEX)\n* Lens status: Aphakic patients or Anterior chamber intraocular lens\n* Previous procedures: Glaucoma shunt\u002Fvalve\u002F surgery or cyclodestructive procedure, Selective laser trabeculoplasty within the past 3 months, Incisional ophthalmic surgery involving the conjunctiva within the past 3 months, Clear corneal cataract or trabecular meshwork surgery conducted within the past 6 months\n* Presence of intraocular silicone oil\n* No light perception vision\n* Current corticosteroid use (ocular or oral)\n* Conjunctival pathologies (e.g., pterygium)\n* Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis)\n* Vitreous present in the anterior chamber\n* Active iris neovascularization or neovascularization of the iris within 6 months of the surgical date\n* Unwillingness or inability to give consent, accept randomization or return for and participate in scheduled protocol visits","21 Years",{"count":60,"type":21},100,[24],"The goal of this randomized controlled clinical trial is to learn whether two minimally invasive bleb-forming glaucoma implants can effectively treat adult patients with open-angle glaucoma who require surgical lowering of intraocular pressure (IOP). Specifically, the study evaluates whether the PRESERFLO™ MicroShunt is at least as effective as the trabeculectomy in reducing IOP after surgery.\n\nThe main questions it aims to answer are:\n\nDoes the PRESERFLO™ MicroShunt provide IOP reduction at 12 months that is non-inferior to trabeculectomy? How do these two surgeries compare over 12 months with respect to medication reduction, need for additional glaucoma procedures, complications, and preservation of visual function and ocular structures?\n\nParticipants will:\n\nBe randomly assigned (1:1) to receive either the trabeculectomy or the PRESERFLO™ MicroShunt during a single glaucoma surgery.\n\nAttend scheduled follow-up visits over 12 months for eye-pressure measurements, vision testing, visual-field testing, OCT imaging, endothelial-cell counts, and safety assessments.\n\nReceive standard postoperative care and report any complications or additional treatments during the study period.",[27],[65],"open angle glaucoma","2026-03-24",{"date":68,"type":42},"2026-03-27",{"date":70,"type":42},"2026-03-01",{"date":72,"type":21},"2028-12-01",{"name":74,"class":49},"Medical University of Bialystok",1,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":17,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100626533","comparison-of-visual-outcomes-and-patient-satisfaction-in-mild-to-moderate-glaucoma-patients-undergoing-cataract-surgery-with-edof-versus-monofocal-iols-100626533","NCT07436871","Comparison of Visual Outcomes and Patient Satisfaction in Mild to Moderate Glaucoma Patients Undergoing Cataract Surgery With EDOF Versus Monofocal IOLs","A Randomized Clinical Trial for the Evaluation and Comparison of Visual Results and Patient Satisfaction in Patients With Primary Open-angle Glaucoma After Bilateral Implantation of an Extended Range of Vision Intraocular Lens Compared to a Monofocal Lens.","Inclusion criteria:\n\n* Patients of any sex aged 18 years or older willing to participate and sign the informed consent form.\n* Clinically significant cataracts in both eyes.\n* Patients clinically diagnosed of primary open angle glaucoma (POAG) in both eyes.\n* Early to moderate POAG, as defined by a mean deviation in the Humphrey Visual Field Analyzer (HFA) no worse than ≤ -12 dB and worse ≥ -2 dB at least in one eye, using a 24-2 SITA standard strategy\n* Two visual field tests without progression and stability of RNFL in Optical Coherence Tomography (OCT) thickness remaining same or less than 10 um in the previous 6 months, with pharmacologically controlled IOP in both eyes \\\u003C21mmHg.\n* Potential for post-surgery monocular distance corrected visual acuity of ≤ 0.10 LogMAR.\n* Normal corneal topography.\n* Able to attend all study visits.\n\nExclusion criteria:\n\n* Patients with uncontrolled glaucoma, defined as those with an IOP ≥21 mm Hg despite maximal medical therapy, requiring glaucoma surgery and\u002For laser in either eye in the next year.\n* Pre-surgery refractive error requiring IOL implantation beyond the commercially available range.\n* Patients with a not reliable visual field, a VFI ≤ 60% or defects of ≤ 10 dB in the 4 central points of the visual field.\n\nAny other form of glaucoma (pseudoexfoliative, severe forms of pigmentary, primary angle closure glaucoma, etc.), ocular hypertension, zonular instability or possible intuitive lens decentration after surgery.\n\n* Patients with any previous glaucoma surgery or any other ocular surgery that can affect the results, or any ocular surgery in the previous six months.\n* Any other ocular pathology that can affect the results.\n* Use of topic or systemic medication that may affect vision\n* Unable to cooperate to obtain consistent testing results.\n* Participation in any other trial during or within 30 days of the screening visit.","18 Years",{"count":85,"type":21},74,[24],"Cataract is the leading cause of reversible vision loss, while glaucoma remains the primary cause of irreversible blindness, often impairing contrast sensitivity (CS), glare tolerance, and dark adaptation. These visual challenges are particularly relevant when selecting intraocular lenses (IOLs) for glaucoma patients undergoing cataract surgery.\n\nMonofocal IOLs are the safest and most commonly used option for glaucoma patients due to their optical simplicity and low incidence of photic phenomena, though they do not provide spectacle independence for near or intermediate vision. Multifocal IOLs (MFIOLs), while offering greater spectacle independence, are relatively contraindicated in glaucoma due to increased visual disturbances like glare and halos.\n\nExtended Depth of Focus (EDOF) IOLs offer an intermediate solution, using advanced optics to provide a continuous range of vision and fewer photic disturbances than MFIOLs. EDOF lenses have demonstrated good uncorrected distance and intermediate visual acuity in patients with mild to moderate glaucoma, with promising CS outcomes and high patient satisfaction. However, findings on CS performance remain inconsistent across studies.\n\nGiven these considerations, this study seeks to determine whether EDOF IOLs can be a viable alternative to monofocal lenses in glaucoma patients, potentially expanding their options for spectacle independence without compromising visual quality. The trial, conducted at OMIQ (Barcelona), will directly compare an EDOF IOL and a monofocal IOL made from the same material to assess their effects on visual acuity, contrast sensitivity, and photic phenomena in this specific patient population.",[27,89],"Cataract",[91,92,93],"cataract surgery","Extended depth of focus intraocular lens","Primary open-angle glaucoma","NOT_YET_RECRUITING","2026-02-23",{"date":97,"type":42},"2026-02-27",{"date":99,"type":21},"2026-01-31",{"date":101,"type":21},"2027-02",{"name":103,"class":104},"OMIQ Research","NETWORK"]