Actively Recruiting
Kahook Dual Blade Goniotomy in Chronic Primary Angle-Closure Glaucoma
Led by Peking University People's Hospital · Updated on 2026-04-08
68
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Kahook Dual Blade Goniotomy in Chronic Primary Angle-Closure Glaucoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Diagnosed with chronic primary angle-closure glaucoma with peripheral anterior synechiae of 180 degrees or more, glaucomatous optic neuropathy, and corresponding visual field defects
- Presence of a visually significant cataract affecting daily activities and requiring phacoemulsification
- Intraocular pressure above 21 mmHg despite maximally tolerated anti-glaucoma medications, or IOP at or below 21 mmHg dependent on two or more topical medications
You will not qualify if you...
- Secondary angle-closure glaucoma such as neovascular, uveitic, or lens-induced glaucoma
- History of intraocular surgery or incisional glaucoma procedures (except uncomplicated laser peripheral iridotomy)
- Severe ocular diseases that seriously impair vision or confound assessments, like severe diabetic retinopathy, advanced age-related macular degeneration, or non-glaucomatous optic atrophy
- Central corneal endothelial cell density below 1500 cells/mm²
- Severe systemic illnesses that prevent surgical tolerance or adherence to the one-year follow-up
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, China, 100044
Actively Recruiting
Research Team
Z
Zhiqiao Liang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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