Phacoemulsification with goniosynechialysis versus trabeculectomy for primary angle-closure glaucoma
Comparison of Phaco Surgery and Goniosynechialysis Versus Trabeculectomy Outcomes in Glaucoma Patients
This trial will see if phacoemulsification plus goniosynechialysis controls eye pressure and causes fewer complications than trabeculectomy in adults with primary angle-closure glaucoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of Medicine and Pharmacy at Ho Chi Minh City Academic / other |
| Locations | 1 site (Ho Chi Minh City) |
| Trial ID | NCT06952153 on ClinicalTrials.gov |
What this trial studies
This randomized, parallel-group, single-masked trial will assign adults with primary angle-closure glaucoma to either phacoemulsification with goniosynechialysis (Phaco-GSL) or trabeculectomy with 5‑fluorouracil. Allocation is stratified by age and disease severity, and all procedures are performed by experienced glaucoma surgeons following standardized surgical and postoperative protocols. Key outcomes include intraocular pressure at predefined intervals, IOP reduction from baseline, rates of postoperative complications, visual acuity recovery, and need for glaucoma medications. Participants attend scheduled visits (e.g., 1 week, 1 month, 3 months, 6 months, 12 months) for standardized eye exams and pressure checks to compare groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 or older with primary angle-closure glaucoma, ≥180° peripheral anterior synechiae, cataract grade 1–3, IOP >21 mmHg despite medication, and BCVA ≥ 0.3 logMAR.
Not a fit: Patients with only light perception vision, secondary angle-closure etiologies, prior ocular surgery or laser PI, very advanced corneal disease, chronic steroid use, very dense cataract (LOCS III grade 4–5), or poor follow-up are unlikely to benefit from randomization in this comparison.
Why it matters
Potential benefit: If successful, Phaco-GSL could provide similar IOP control with fewer complications and faster visual recovery than trabeculectomy.
How similar studies have performed: Previous nonrandomized studies and smaller series have suggested Phaco-GSL can lower IOP and reduce medication need in PACG, but high-quality randomized comparisons directly versus trabeculectomy are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Ho Chi Minh City
- HCMC University of Medicine and Pharmacy — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Study coordinator: Hai Thanh Le, MSc
- Email: haileopto@gmail.com
- Phone: +61 450390405
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.