An interventional study of Phacoemulsification with Goniosynechialysis and Trabeculectomy with 5FU in Primary Angle Closure Glaucoma, sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Recruiting at 1 site in Vietnam. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
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:
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
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.
91 studies on the registry are indexed under Glaucoma, Angle-Closure; 17 are open to participants now.
This study's planned enrollment of 82 is above the median of 57 across 58 interventional studies indexed under Glaucoma, Angle-Closure.
Browse Glaucoma, Angle-Closure studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: Trabeculectomy with 5FU
Procedure: Phacoemulsification with Goniosynechialysis
This 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.
Also known as: Phaco-GSL
Trabeculectomy 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.
Time frame: 12 months after surgery
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.
Time frame: 12 months postoperatively
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.
Time frame: 12 months postoperatively
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.
Time frame: 12 months postoperatively
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.
Time frame: 12 months after surgery
Plan to share: Yes — Individual participant data (IPD) that underlie the results reported in the publication (after de-identification) will be shared, including baseline characteristics, intraocular pressure (IOP) values, visual acuity measurements, surgical outcomes, and complication rates. A data dictionary will be provided to facilitate reuse.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be available beginning 6 months after publication of the study results and will remain accessible for 2 years.
Access criteria: Access will be granted to qualified researchers affiliated with academic institutions, non-profit organizations, or healthcare institutions conducting non-commercial research. Requests must include a research proposal and data use agreement. Requests will be reviewed by the study's data access committee.
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