Comparison of Phaco Surgery With Goniosynechialysis Versus Trabeculectomy in Glaucoma Treatment

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.

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

• Very advanced glaucoma (only light perception vision)
• Secondary angle-closure etiologies
• Prior ocular surgeries or laser peripheral iridotomy (PI)
• Allergy to 5-fluorouracil (5-FU), if used postoperatively
• Irreversible corneal disease
• Chronic corticosteroid use
• Poor follow-up compliance
• Cataract grade 4 or 5 (LOCS III)
• Phacomorphic, phacolytic, or subluxated cataracts