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Kahook Dual Blade Goniotomy in Chronic Primary Angle-Closure Glaucoma

RecruitingNAAges 40 Years - anyAllPeking University People's Hospital
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In plain words

What the trial is, and whether it could suit you

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 โ‰ค21 mmHg with a โ‰ฅ20% reduction from baseline, with or without topical hypotensive medications), and secondary outcomes include intra- and post-operative complications and changes in peripheral anteri

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * (1) age โ‰ฅ 40 years; (2) a confirmed diagnosis of CPACG, defined as the presence of peripheral anterior synechiae (PAS) extending โ‰ฅ 180ยฐ on indentation gonioscopy, accompanied by glaucomatous optic neuropathy and corresponding visual field defects; (3) a visually significant cataract that impaired daily activities and necessitated phacoemulsification; and (4) inadequately controlled intraocular pressure (IOP), defined as an IOP \> 21 mmHg despite maximally tolerated anti-glaucoma medications, or an IOP โ‰ค 21 mmHg dependent on the continuous use of two or more topical medications. Exclusion Criteria: * (1) any form of secondary angle-closure glaucoma (e.g., neovascular, uveitic, or lens-induced glaucoma); (2) a history of prior intraocular surgery or incisional glaucoma procedures, although eyes with a previous uncomplicated laser peripheral iridotomy (LPI) were permitted; (3) concurrent severe ocular pathologies that could profoundly limit visual prognosis or confound functional assessments (e.g., severe diabetic retinopathy, advanced age-related macular degeneration, or optic atrophy of non-glaucomatous origin); (4) a central corneal endothelial cell density of \< 1500 cells/mmยฒ to ensure the safety of the planned anterior chamber interventions; and (5) any severe systemic conditions precluding surgical tolerance or adherence to the 1-year follow-up protocol.
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What it tests

  • Kahook Dual Blade (KDB) goniotomy
  • phacoemulsification with intraocular lens implantation combined with goniosynechialysis
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Where

1 site
Peking University People's Hospital
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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