Comparison of Phaco Surgery With Goniosynechialysis Versus Trabeculectomy in Glaucoma Treatment

NCT06952153 | Recruiting DMC

• 1 other identifier: Ho Chi Minh City UMP
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Angle Closure Glaucoma

Keywords

PACG; Phaco-GSL; trabeculectomy; RCT; Ophthalmic surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after surgery

Secondary Outcomes (4)

• Change in best-corrected visual acuity (BCVA) from baseline

  12 months postoperatively

• Change in number of glaucoma medications from baseline

  12 months postoperatively

• Change in Total Degree of Angle Closure from Baseline

  12 months postoperatively

• Surgical Success Rate

  12 months after surgery

Study Arms (2)

standard trabeculectomy with 5FU

ACTIVE COMPARATOR

Procedure: Trabeculectomy with 5FU

Phacoemulsification with Goniosynechialysis

EXPERIMENTAL

Procedure: Phacoemulsification with Goniosynechialysis

Interventions

Phacoemulsification with Goniosynechialysis 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.

Also known as: Phaco-GSL

Phacoemulsification with Goniosynechialysis

Trabeculectomy with 5FU 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.

standard trabeculectomy with 5FU

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Medicine and Pharmacy at Ho Chi Minh City: lead

Study Sites (1)

HCMC University of Medicine and Pharmacy

Ho Chi Minh City, Vietnam

RECRUITING

Related Publications (2)

• Liu Y, Li W, Jiu X, Lei X, Liu L, Yan C, Li X. Systematic Review and Meta-Analysis of Comparing Phacoemulsification Combined with goniosynechialysis to other mainstream procedures in treating patients with angle-closure glaucoma. Medicine (Baltimore). 2019 Oct;98(42):e17654. doi: 10.1097/MD.0000000000017654.

  PMID: 31626152 BACKGROUND

• Zhao J, Zhang C, Pazo EE, Dai G, Li Y, Chen Y, Li M, Che H. Phaco-goniosynechialysis versus phaco-trabeculectomy in patients with refractory primary angle-closure glaucoma: a comparative study. BMC Ophthalmol. 2023 Apr 6;23(1):144. doi: 10.1186/s12886-023-02885-6.

  PMID: 37024836 BACKGROUND

MeSH Terms

Conditions

Glaucoma, Angle-Closure

Interventions

Phacoemulsification; Trabeculectomy; Fluorouracil

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Cataract Extraction; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative; Ultrasonic Surgical Procedures; Filtering Surgery; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Hai Thanh Le, MSc

CONTACT

+61 450390405; haileopto@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator, Department of Ophthalmology

Model Details: 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.

Study Record Dates

• First Submitted: April 23, 2025
• First Posted: April 30, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): September 10, 2027
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

VN (1)