Condition: Primary Angle-closure Glaucoma · Sponsor: Peking University People's Hospital
This prospective randomized controlled trial, conducted by the Ophthalmology Department of Peking University People's Hospital, aims to compare the intraocular pressure (IOP)-lowering efficacy and safety of two surgical regimens-phacoemulsification with intraocular lens implantation plus goniosynechialysis (PEI-GSL) and PEI-GSL combined with Kahook Dual Blade (KDB) ab interno goniotomy (PEI-GSL-KDB)-in 68 patients (34 eyes per group) with chronic primary angle-closure glaucoma (PACG) complicated by age-related cataract. All surgeries are performed by senior glaucoma specialists, with a 1-year follow-up for outcomes assessment. The primary outcome is the 12-month IOP control success rate (IOP ≤21 mmHg with a ≥20% reduction from baseline, with or without topical hypotensive medications), and secondary outcomes include intra- and post-operative complications and changes in peripheral anterior synechiae (PAS). Statistical analyses will use t-tests, chi-square tests, etc., with P\<0.05 considered statistically significant. The study is scheduled from January 2024 to December 2025, and preliminary research has confirmed the safety and efficacy of combined glaucoma-cataract surgeries, laying a solid foundation for this trial.
This description comes directly from the study's public registry record.
Zhiqiao Liang, Doctor · 8613621338839 · lzqliangzhiqiao@163.com
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| Peking University People's Hospital | Beijing, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07517302