Comparison of Phaco Surgery With Goniosynechialysis Versus Trabeculectomy in Glaucoma Treatment

University of Medicine and Pharmacy at Ho Chi Minh City

Status

Enrolling

Conditions

Primary Angle Closure Glaucoma

Treatments

Procedure: Trabeculectomy with 5FU

Procedure: Phacoemulsification with Goniosynechialysis

Study type

Interventional

Funder types

Other

Identifiers

NCT06952153

Ho Chi Minh City UMP

Details and patient eligibility

About

The goal of this clinical trial is to learn whether phacoemulsification combined with goniosynechialysis (Phaco-GSL) is as effective and safe as trabeculectomy in treating patients with primary angle-closure glaucoma.

The main questions it aims to answer are:

Does Phaco-GSL provide similar or better intraocular pressure (IOP) control compared to trabeculectomy?
What are the rates of postoperative complications or adverse events between the two surgical approaches?
How do the two procedures compare in terms of visual acuity recovery and need for glaucoma medications?

Researchers will compare Phaco-GSL to trabeculectomy to determine which procedure offers better overall outcomes for patients with angle-closure glaucoma.

Participants will:

Be randomly assigned to undergo either Phaco-GSL or trabeculectomy Attend scheduled follow-up visits at regular intervals (e.g., 1 week, 1 month, 3 months, 6 months, 12 months) for eye exams and pressure checks

Full description

This clinical trial is designed to compare the clinical efficacy and safety of two surgical interventions for patients with primary angle-closure glaucoma (PACG): (1) phacoemulsification combined with goniosynechialysis (Phaco-GSL), and (2) trabeculectomy. The study is driven by the increasing need to identify surgical approaches that not only provide effective intraocular pressure (IOP) control but also minimize postoperative complications and preserve visual function.

Phacoemulsification with goniosynechialysis aims to address both lens-induced angle crowding and peripheral anterior synechiae (PAS), potentially restoring aqueous outflow through a less invasive approach than trabeculectomy. On the other hand, trabeculectomy remains the gold standard for glaucoma filtration surgery and offers significant IOP reduction, albeit with a higher risk of complications and need for intensive postoperative care.

This randomized, parallel-group, single masked interventional trial will allocate participants to undergo either Phaco-GSL or trabeculectomy. Allocation will be stratified based on key baseline factors age, condition severity and type. All surgical procedures will be performed by experienced glaucoma surgeons following standardized protocols. Postoperative management will be unified across both groups to ensure comparability of outcomes.

Primary and secondary endpoints will include postoperative IOP at predefined intervals, reduction in IOP from baseline, number of anti-glaucoma medications required, visual acuity outcomes, angle status (via gonioscopy), and occurrence of adverse events. Follow-up will extend for at least 12 months to capture both short-term surgical success and medium-term complications or failures.

This trial will provide much-needed data to inform clinical decisions in managing PACG, particularly in cases where lens extraction is indicated. By comparing a combined lens-based and angle-opening procedure to a traditional filtering surgery, the study seeks to clarify the relative benefits and risks of each approach.

Enrollment

82 estimated patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥ 40 years
Peripheral anterior synechiae (PAS) >180°
Glaucomatous optic neuropathy with visual field loss
Intraocular pressure (IOP) > 21 mmHg despite medication
Ability to consent and comply with follow-up
Cataract grade 1 to 3 according to LOCS III
Best corrected visual acuity (BCVA) ≥ 0.3 logMAR (equivalent to 20/40 Snellen or worse)

Exclusion criteria