[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645685":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":85,"collaborators":25,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":25,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":25,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":25,"overallStatus":47,"whyStopped":25,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Nanfang Hospital, Southern Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PEI combined with gonioscopy-assisted trabeculotomy","EXPERIMENTAL","Participants will undergo phacoemulsification cataract extraction with intraocular lens implantation combined with approximately 120 degrees of ab interno gonioscopy-assisted trabeculotomy during the same surgical session. Postoperative care will follow the protocol, and rescue IOP-lowering medications may be added if clinically indicated.",[13],"Combination Product: PEI combined with gonioscopy-assisted trabeculotomy",{"label":15,"type":16,"description":17,"interventionNames":18},"PEI combined with conventional IOP-lowering medications","ACTIVE_COMPARATOR","Participants will undergo phacoemulsification cataract extraction with intraocular lens implantation. Postoperatively, conventional topical IOP-lowering medications will be initiated or adjusted according to guideline-based care and clinical judgment when IOP remains above target.",[19],"Combination Product: PEI combined with conventional topical IOP-lowering medications",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"COMBINATION_PRODUCT","Phacoemulsification combined with Ab interno trabeculotomy performed under gonioscopic visualization for approximately 120 degrees to incise\u002Fopen the trabecular meshwork and expose Schlemm canal. The cutting instrument will be non-device-dependent, such as a Tanito hook, Lanxin knife, Zeng knife, or bent 25-26G needle; KDB is not included as the cutting blade.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"PEI combined with conventional topical IOP-lowering medications","Phacoemulsification combined with guideline-based topical IOP-lowering therapy, generally including prostaglandin analogues unless contraindicated, with beta-blockers, carbonic anhydrase inhibitors, alpha-2 agonists, or other agents added or adjusted according to efficacy, tolerance, contraindications, and clinical judgment.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Hongyang Zhang, PhD","CONTACT","+86-20-62787325","hy3005716@163.com",{"name":37,"role":33,"phone":25,"phoneExt":25,"email":38},"Yuqiao Zhang, PhD","yqzhang@link.cuhk.edu.hk",[40,46,58,66,77],{"facility":41,"status":42,"city":43,"state":43,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":25,"geoPoint":25,"contacts":25},"People's Hospital of Ningxia Hui Autonomous Region","NOT_YET_RECRUITING","Ningxia","China","CN",{"facility":5,"status":47,"city":48,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Guangzhou",{"type":50,"coordinates":51},"Point",[52,53],113.25,23.11667,{"lat":53,"lon":52},[56],{"name":57,"role":33,"phone":34,"phoneExt":25,"email":35},"Hongyang Zhang",{"facility":59,"status":42,"city":60,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":25},"The Affiliated Hospital of Southwest Medical University","Luzhou",{"type":50,"coordinates":62},[63,64],105.42575,28.8903,{"lat":64,"lon":63},{"facility":67,"status":42,"city":68,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou",{"type":50,"coordinates":70},[71,72],113.64861,34.75778,{"lat":72,"lon":71},[75],{"name":76,"role":33,"phone":25,"phoneExt":25,"email":25},"Xin Yang",{"facility":78,"status":42,"city":79,"state":25,"zip":25,"country":44,"countryCode":45,"cosmosGeoPoint":80,"geoPoint":84,"contacts":25},"Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine","Zhuhai",{"type":50,"coordinates":81},[82,83],113.56778,22.27694,{"lat":83,"lon":82},{"type":86,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100645685","pei-gt-trial-for-initial-treatment-of-primary-open-angle-glaucoma-with-cataract-100645685",false,"NCT07700498","PEI-GT Trial for Initial Treatment of Primary Open-Angle Glaucoma With Cataract","Efficacy and Safety of Phacoemulsification Combined With Gonioscopy-Assisted Trabeculotomy as Initial Treatment for Primary Open-Angle Glaucoma With Cataract: A Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n* Provides written informed consent voluntarily.\n* Age 40 to 85 years.\n* Male or female.\n* Treatment-naive for glaucoma, with no prior IOP-lowering medication, glaucoma laser procedure, or glaucoma surgery.\n* Lens opacity causing decreased visual quality and clinically significant cataract.\n* Diagnosis of POAG combined with cataract by the treating ophthalmologist.\n* Best-corrected visual acuity of 0.1 or better on the Snellen chart, corresponding to LogMAR 1.0 or less.\n* Ability and willingness to complete scheduled follow-up visits and study examinations.\n\nExclusion Criteria:\n\n* Secondary glaucoma, including uveitic, pseudoexfoliative, pigmentary, steroid-induced, neovascular, traumatic, or other secondary glaucoma.\n* Angle-closure glaucoma or narrow angle inconsistent with POAG.\n* POAG without visually significant cataract.\n* Previous anti-glaucoma medication use, glaucoma surgery, or glaucoma laser treatment.\n* Advanced visual field loss, defined as visual field mean deviation worse than -12 dB.\n* Severe ocular comorbidity or inability to perform reliable visual acuity testing.\n* Known contraindication to required study medications.\n* Average RNFL thickness or GCIPL thickness less than 54 micrometers.\n* Axial length greater than 26 mm.\n* Monocular status or functional vision in only one eye.\n* Inability to complete reliable visual field or OCT testing.\n* Systemic disease that may affect ocular status or study assessment, including diabetes mellitus, uncontrolled hypertension, malignancy, renal disease, autoimmune disease, neurological disease, liver disease, cardiovascular disease, or systemic inflammatory disease.\n* Visual impairment mainly attributable to disease other than POAG or cataract.\n* Pregnancy, lactation, or planned pregnancy during the study period.","ALL","40 Years","85 Years",{"count":98,"type":99},106,"ESTIMATED","INTERVENTIONAL",[102],"NA","The goal of this clinical trial is to learn whether doing phacoemulsification combined with gonioscopy-assisted trabeculotomy as an initial treatment can reduce the burden of glaucoma eye drops in adults with primary open-angle glaucoma and cataract. It will also learn whether this early surgical strategy improves ocular surface health and vision-related quality of life. The main questions it aims to answer are:\n\nDoes early combined surgery reduce the need for long-term glaucoma medications? Does early combined surgery improve ocular surface health compared with cataract surgery followed by guideline-based glaucoma eye drops? Does early combined surgery improve vision-related quality of life and anxiety compared with the medication-based treatment strategy? What medical problems or complications do participants have after treatment? Researchers will compare phacoemulsification combined with gonioscopy-assisted trabeculotomy to phacoemulsification followed by guideline-based topical eye pressure-lowering medications.\n\nParticipants will:\n\nUndergo cataract surgery with or without gonioscopy-assisted trabeculotomy Attend follow-up visits for 24 months after treatment Have eye pressure, visual acuity, OCT, AS-OCT, visual field, ocular surface, and safety examinations at scheduled visits Complete quality-of-life and anxiety questionnaires at scheduled visits Provide tear samples at selected visits for biomarker testing where applicable",[105],"Primary Open Angle Glaucoma and Cataracts","2026-07-07",{"date":108,"type":109},"2026-07-14","ACTUAL",{"date":111,"type":99},"2026-07-15",{"date":113,"type":99},"2030-12-31",{"name":5,"class":6},5]