Comparison of Phaco Surgery With Goniosynechialysis Versus Trabeculectomy in Glaucoma Treatment

Официальное название

Comparison of Phaco Surgery and Goniosynechialysis Versus Trabeculectomy Outcomes in Glaucoma Patients

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Mean change in intraocular pressure (IOP) from baseline [Срок оценки: 12 months after surgery]

Вторичные конечные точки (4)

• Change in best-corrected visual acuity (BCVA) from baseline [Срок оценки: 12 months postoperatively]
• Change in number of glaucoma medications from baseline [Срок оценки: 12 months postoperatively]
• Change in Total Degree of Angle Closure from Baseline [Срок оценки: 12 months postoperatively]
• Surgical Success Rate [Срок оценки: 12 months after surgery]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Вьетнам · 1 центр

• HCMC University of Medicine and Pharmacy — Ho Chi Minh City

Публикации

• 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
• 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

Идентификаторы

NCT: NCT06952153 · Ho Chi Minh City UMP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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