Kahook Dual Blade goniotomy added to cataract surgery for chronic angle-closure glaucoma
Phacoemulsification and Goniosynechialysis With or Without Kahook Dual Blade Goniotomy in Chronic Primary Angle-Closure Glaucoma: A 1-Year Randomized Controlled Trial
This trial will test whether adding Kahook Dual Blade goniotomy to cataract surgery and goniosynechialysis better lowers eye pressure in people aged 40 and older with chronic primary angle-closure glaucoma and cataract.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 68 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Peking University People's Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT07517302 on ClinicalTrials.gov |
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).
Who should consider this trial
Good fit: Ideal candidates are people aged 40 or older with chronic primary angle-closure glaucoma involving ≥180° peripheral anterior synechiae, a visually significant cataract, and inadequately controlled IOP despite medical therapy.
Not a fit: Patients with secondary angle-closure glaucoma, prior intraocular or incisional glaucoma surgery, severe coexisting ocular disease that limits visual prognosis, or those without a clinically significant cataract are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, adding KDB goniotomy could lower intraocular pressure more, reduce the need for glaucoma medications, and preserve the conjunctiva for future surgeries.
How similar studies have performed: Smaller nonrandomized reports have shown substantial IOP and medication reductions after PEI-GSL combined with KDB in PACG, but larger randomized controlled data have been lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Beijing
- Peking University People's Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Zhiqiao Liang, Doctor
- Email: lzqliangzhiqiao@163.com
- Phone: 8613621338839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.