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
Age ≥ 40 years
Peripheral anterior synechiae (PAS) >180°
Glaucomatous optic neuropathy with visual field loss
Intraocular pressure (IOP) > 21 mmHg despite medication
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
Parallel
Phacoemulsification with Goniosynechialysis
Procedure/SurgeryThis procedure involves standard phacoemulsification cataract surgery combined with goniosynechialysis, which mechanically separates peripheral anterior synechiae to open the anterior chamber angle. It aims to both remove the cataractous lens and restore aqueous outflow in patients with primary angle-closure glaucoma.
Trabeculectomy with 5FU
Procedure/SurgeryTrabeculectomy is a glaucoma filtration procedure designed to lower intraocular pressure by creating a new drainage pathway from the anterior chamber to the sub-conjunctival space. It is considered the standard surgical intervention for medically uncontrolled glaucoma.
Mean change in intraocular pressure (IOP) from baseline
The primary outcome is the mean reduction in intraocular pressure (IOP) measured in mmHg from baseline to the final follow-up visit. IOP will be measured using Goldmann applanation tonometry by a masked outcomes assessor. The purpose is to evaluate the effectiveness of phacoemulsification combined with goniosynechialysis compared to standard trabeculectomy in reducing IOP in patients with primary angle-closure glaucoma.
Change in best-corrected visual acuity (BCVA) from baseline
This outcome measures the change in best-corrected visual acuity (BCVA), expressed in logMAR units, from baseline to the final follow-up visit. BCVA will be assessed using standardized ETDRS charts under consistent lighting and testing conditions. The aim is to compare the improvement or decline in visual acuity between participants undergoing phacoemulsification with goniosynechialysis and those undergoing trabeculectomy. Measurements will be conducted by certified examiners masked to group allocation.
Change in number of glaucoma medications from baseline
This outcome assesses the difference in the number of topical anti-glaucoma medications used by participants before and after surgery. The total number of medications will be recorded at baseline and at each follow-up visit. The goal is to determine whether phacoemulsification with goniosynechialysis reduces the need for ongoing pharmacological treatment compared to trabeculectomy. A reduction in medication burden is considered an indicator of treatment efficacy and improved patient quality of life.
Change in Total Degree of Angle Closure from Baseline
This outcome measure evaluates the change in the extent of angle closure, quantified as the total degrees of the anterior chamber angle that are closed, from baseline to the final follow-up. Assessments will be performed using standardized gonioscopy or anterior segment imaging (e.g., AS-OCT) by examiners masked to treatment allocation. The measurement provides an objective indicator of the anatomical improvement of the angle following intervention, with a reduction in closed angle degrees suggesting a more open drainage pathway, which is critical for effective intraocular pressure control.
Surgical Success Rate
Surgical success will be classified into two categories: Complete Success: Defined by meeting all of the following criteria: Postoperative intraocular pressure (IOP) consistently between 5 mmHg and 18 mmHg at each follow-up visit without the use of additional anti-glaucoma medications. A ≥20% reduction in IOP from baseline (preoperative value). No need for additional surgical intervention to manage glaucoma. No use of adjunctive glaucoma medications. Partial Success: Defined as meeting some but not all criteria for complete success. This may include cases where IOP is within target range but maintained with the aid of medications, or the percentage IOP reduction is less than 20%. This outcome provides a comprehensive assessment of surgical effectiveness and will be evaluated at 12 months postoperatively.
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