Primary Angle Closure GlaucomaNCT06952153
Comparison of Phaco Surgery With Goniosynechialysis Versus Trabeculectomy in Glaucoma Treatment
A study testing Phacoemulsification with Goniosynechialysis and Trabeculectomy with 5FU in people with Primary Angle Closure Glaucoma, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Primary Angle Closure Glaucoma
- What is being tested?
- Phacoemulsification with Goniosynechialysis and Trabeculectomy with 5FU
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteVietnam
- Study dates
- 1 Jun 2025to 10 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- Poor follow-up compliance
- Cataract grade 4 or 5 (LOCS III)
- Phacomorphic, phacolytic, or subluxated cataracts
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam1 site, 1 recruiting
- Recruiting
HCMC University of Medicine and Pharmacy
Ho Chi Minh City
Phuc Hoang Nguyen, MD, +84 983826797, dr.nguyenhoangphuc@ump.edu.vn
About this study
Official title: Comparison of Phaco Surgery and Goniosynechialysis Versus Trabeculectomy Outcomes in Glaucoma Patients
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:
Read more
- 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
Read the detailed description
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
- Primary Angle Closure Glaucoma
- Being tested
- Phacoemulsification with Goniosynechialysis, Trabeculectomy with 5FU
- Keywords
- PACG, Phaco-GSL, trabeculectomy, RCT, Ophthalmic surgery
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phacoemulsification with GoniosynechialysisProcedure or surgery
Also called Phaco-GSL
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.
Trabeculectomy with 5FUProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| standard trabeculectomy with 5FU | Active comparator | Not described Receives: Procedure: Trabeculectomy with 5FU |
| Phacoemulsification with Goniosynechialysis | Experimental | Not described Receives: Procedure: Phacoemulsification with Goniosynechialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after surgery
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start1 Jun 2025
- Primary completion30 Jul 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Angle Closure GlaucomaStudies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nguyen Hoang Phuc, University of Medicine and Pharmacy at Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06952153
- Sponsor's protocol ID
- Ho Chi Minh City UMP
- Status last verified
- Sep 2025
- First submitted
- 23 Apr 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 31626152Zhao 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.
PubMed 37024836
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Phaco Surgery and Goniosynechialysis Versus Trabeculectomy Outcomes in Glaucoma Patients
- ClinicalTrials.gov ID
- NCT06952153
- Acronym / sponsor ID
- Ho Chi Minh City UMP
- Conditions
- Primary Angle Closure Glaucoma
- Keywords
- PACG, Phaco-GSL, trabeculectomy, RCT, Ophthalmic surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jul 2027 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| standard trabeculectomy with 5FU | Active comparator | Procedure: Trabeculectomy with 5FU |
| Phacoemulsification with Goniosynechialysis | Experimental | Procedure: Phacoemulsification with Goniosynechialysis |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phacoemulsification with GoniosynechialysisAlso: Phaco-GSLThis 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. | Procedure or surgery | Phacoemulsification with Goniosynechialysis |
| Trabeculectomy with 5FUTrabeculectomy 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. | Procedure or surgery | standard trabeculectomy with 5FU |
Primary outcome
Mean change in intraocular pressure (IOP) from baseline
Time frame: 12 months after surgery
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.
4 secondary outcomes
Change in best-corrected visual acuity (BCVA) from baseline
Time frame: 12 months postoperatively
Change in number of glaucoma medications from baseline
Time frame: 12 months postoperatively
Change in Total Degree of Angle Closure from Baseline
Time frame: 12 months postoperatively
Surgical Success Rate
Time frame: 12 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 31626152Liu 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.
- Background: PubMed 37024836Zhao 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phacoemulsification with Goniosynechialysis and Trabeculectomy with 5FU in people with Primary Angle Closure Glaucoma, run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hai Thanh Le, MSc (+61 450390405, haileopto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in intraocular pressure (IOP) from baseline (time frame: 12 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06952153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.