Comparison of Phaco Surgery With Goniosynechialysis Versus Trabeculectomy in Glaucoma Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-01

Study Completion Date

2027-09-10

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Primary Angle Closure Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a prospective, randomized, parallel-group interventional trial. Eligible participants with primary angle-closure glaucoma will be randomly assigned in a 1:1 ratio to undergo either phacoemulsification with goniosynechialysis (Phaco-GSL) or standard trabeculectomy. Randomization will be stratified by baseline age, condition severity and type. All surgical procedures will follow a standardized protocol, and postoperative care will be identical between groups. The primary analysis will compare postoperative intraocular pressure (IOP) and surgical success rates over a 12-month follow-up period.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

This is a triple-masked randomized controlled trial with masking of the outcome assessor and data analyst. The surgeon was unmasked due to the nature of surgical interventions, and patients were masked to the study hypothesis.

Study Groups

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standard trabeculectomy with 5FU

Group Type ACTIVE_COMPARATOR

Trabeculectomy with 5FU

Intervention Type PROCEDURE

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.

Phacoemulsification with Goniosynechialysis

Group Type EXPERIMENTAL

Phacoemulsification with Goniosynechialysis

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Trabeculectomy with 5FU

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.

Intervention Type PROCEDURE

Other Intervention Names

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Phaco-GSL

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No