MedTrace Logo

Kahook Dual Blade Goniotomy in Chronic Primary Angle-Closure Glaucoma

NCT07517302 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-04-08

No results posted yet for this 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.

Conditions

  • Primary Angle-closure Glaucoma

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-01
Primary Completion
2025-09-01
Completion
2026-07-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07517302 on ClinicalTrials.gov