Kahook Dual Blade goniotomy added to cataract surgery for chronic angle-closure glaucoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective randomized controlled trial that will enroll 68 eyes with chronic primary angle-closure glaucoma (PACG) and visually significant cataract, randomized 1:1 to phacoemulsification with intraocular lens implantation plus goniosynechialysis (PEI-GSL) either with or without Kahook Dual Blade (KDB) ab interno goniotomy. All procedures are performed by senior glaucoma specialists and patients are followed for 12 months. The primary outcome is 12-month IOP control success (IOP ≤21 mmHg with ≥20% reduction from baseline, with or without topical medications). Secondary outcomes include intra- and postoperative complications and changes in peripheral anterior synechiae (PAS).

Why it matters

Who can join: the full rules

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.

Where it's running

• Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Zhiqiao Liang, Doctor
• Email: lzqliangzhiqiao@163.com
• Phone: 8613621338839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.