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
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: Does 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. Participants will: Undergo 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
• Provides written informed consent voluntarily.
• Age 40 to 85 years.
• Male or female.
• Treatment-naive for glaucoma, with no prior IOP-lowering medication, glaucoma laser procedure, or glaucoma surgery.
• Lens opacity causing decreased visual quality and clinically significant cataract.
• Diagnosis of POAG combined with cataract by the treating ophthalmologist.
• Best-corrected visual acuity of 0.1 or better on the Snellen chart, corresponding to LogMAR 1.0 or less.
• Ability and willingness to complete scheduled follow-up visits and study examinations.