Kahook Dual Blade Goniotomy in Chronic Primary Angle-Closure Glaucoma

NCT07517302 | Recruiting DMC

• 1 other identifier: PekingUPHOphthalmology002
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Angle-closure Glaucoma

Keywords

KDB Goniotomy; Phacoemulsification; Intraocular Pressure; Goniosynechialysis

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  IOP by Goldmann

  1 month/3 months/6 months/12 months postoperatively

Study Arms (2)

PEI-GSL

ACTIVE COMPARATOR

For the control group (PEI-GSL), 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. This mechanical dissection effectively separated the PAS from the angle wall and successfully exposed the underlying TM.

Device: phacoemulsification with intraocular lens implantation combined with goniosynechialysis

PEI-GSL-KDB

EXPERIMENTAL

For the experimental group (PEI-GSL-KDB), excisional goniotomy was performed immediately following the standardized PEI and GSL procedures. Once the PAS were completely separated and the TM was adequately exposed, the Kahook Dual Blade (KDB; New World Medical, Rancho Cucamonga, CA, USA) was introduced into the anterior chamber through the primary clear corneal incision. Under direct gonioscopic visualization, the sharp distal tip of the KDB was used to pierce the diseased TM, and the heel of the device was carefully seated against the anterior/outer wall of Schlemm's canal. The instrument was then advanced smoothly along the trajectory of the canal to excise a continuous strip of TM spanning approximately 4 clock hours (120°) in the nasal quadrant. The excised, free-floating TM strip was subsequently extracted using intraocular microforceps.

Device: Kahook Dual Blade (KDB) goniotomy

Interventions

Kahook Dual Blade (KDB) goniotomy DEVICE

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.

PEI-GSL-KDB

phacoemulsification with intraocular lens implantation combined with goniosynechialysis DEVICE

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.

PEI-GSL

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

Trabeculectomy; Phacoemulsification

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Cataract Extraction; Refractive Surgical Procedures; Ultrasonic Surgical Procedures

Central Study Contacts

Zhiqiao Liang, Doctor

CONTACT

8613621338839; lzqliangzhiqiao@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Given the distinct nature of the surgical procedures, it was not feasible to mask the operating surgeons and the patients to the treatment allocation. To mitigate potential detection bias, an assessor-blinded protocol was strictly implemented. All postoperative clinical evaluations, prominently including the measurement of IOP and gonioscopic examinations, were conducted by independent clinical assessors who remained entirely masked to the patients' randomization assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: March 1, 2025
• Primary Completion: September 1, 2025
• Study Completion: July 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)