NCT07517302 Kahook Dual Blade Goniotomy in Chronic Primary Angle-Closure Glaucoma
| NCT ID | NCT07517302 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University People's Hospital |
| Condition | Primary Angle-closure Glaucoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 68 participants in total. It began in 2025-03-01 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07517302 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Primary Angle-closure Glaucoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07517302 currently recruiting?
Yes, NCT07517302 is actively recruiting participants. Contact the research team at lzqliangzhiqiao@163.com for enrollment information.
Where is the NCT07517302 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07517302 clinical trial?
NCT07517302 is sponsored by Peking University People's Hospital. The trial plans to enroll 68 participants.