Kahook Dual Blade Goniotomy in Chronic Primary Angle-Closure Glaucoma
Recruiting now · Not applicable
Conditions studied: Primary Angle-closure Glaucoma
In brief
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.
Key facts
- Study ID
- NCT07517302
- Run by
- Peking University People's Hospital
- People needed
- 68
- Starts
- 2025-03-01
- Expected to finish
- 2026-07-01
- Last updated by the study team
- 2026-04-08
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- (1) age ≥ 40 years; (2) a confirmed diagnosis of CPACG, defined as the presence of peripheral anterior synechiae (PAS) extending ≥ 180° 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 ≤ 21 mmHg dependent on the continuous use of two or more topical medications.
You may not qualify if…
- (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/mm² 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.
Where it is running
- Peking University People's Hospital — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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