Kahook Dual Blade Goniotomy in Chronic Primary Angle-Closure Glaucoma

NCT07517302 · tracked via the Priya Life Science China tracker

Sponsor

Peking University People's Hospital

Phase

Not applicable

Started

2025-03-01

Last updated

2026-04-08

Condition(s) studied

Primary Angle-closure Glaucoma

Investigational drug(s) / intervention(s)

Kahook Dual Blade (KDB) goniotomyphacoemulsification with intraocular lens implantation combined with goniosynechialysis

Kahook Dual Blade (KDB) goniotomy: he Kahook Dual Blade (KDB) is an ab interno device engineered to precisely excise a strip of diseased TM and the inner wall of Schlemm's canal.

phacoemulsification with intraocular lens implantation combined with goniosynechialysis: patients underwent standard phacoemulsification with IOL implantation, followed by GSL. Briefly, after the IOL was securely placed in the capsular bag, a cohesive ophthalmic viscosurgical device (OVD) was injected to deepen the anterior chamber and widen the iridocorneal angle. The patient's head was rotated approximately 30 to 45 degrees away from the surgeon, and the operating microscope was tilted toward the surgeon to optimize the visualization of the nasal angle. Under direct gonioscopic guidance using a surgical gonioprism, a blunt instrument (e.g., a cyclodialysis spatula or iris sweep) was used to apply gentle posterior and centripetal pressure to the peripheral iris.

Study summary

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.

Eligibility

Sex

ALL

Min age

40 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * (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. 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/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.

Primary outcome measure(s)

Intraocular pressure — 1 month/3 months/6 months/12 months postoperatively
IOP by Goldmann

Trial sites (1)

Facility	City	Region	Status
Peking University People's Hospital	Beijing	China	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07517302 on ClinicalTrials.gov ↗ ← All trials in China