Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG

Study Overview
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Brief Summary
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A multicenter, parallel, open, non-inferior randomized controlled trial is conducted to compare the effectiveness and safety of trabeculectomy and peripheral iridectomy plus goniotomy (TVG) in the treatment of advanced primary angle closure glaucoma with no or mild cataracts.

Detailed Description
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Primary angle-closure glaucoma (PACG) has a high prevalence and blinding rate in China. The routine first-line treatment of advanced PACG is trabeculectomy, especially in those without cataract. However, due to surgery complications and exhausting post-surgery caring, traditional trabeculectomy is not an ideal choice in clinical practice, particularly in patients with high risk of complications such as younger age and shorter axial length. Peripheral iridectomy (SPI) plus intraocular pressure (IOP)-lowering medications is an alternative. Minimally invasive glaucoma surgery (MIGS) has recently showed its safety and effectiveness in the treatment of PACG, usually combined with cataract surgery, goniosynechialysis (GSL) and goniotomy(GT). The safety and effectiveness of phacoemulsification and intraocular lens implantation (PEI)+GSL+GT in advanced PACG with cataract has been conducted (clinical trials.gov, NCT04878458). It is valuable to explore the safety and efficacy of SPI+GSL+GT in these PACG patients with no or mild cataracts. Therefore, this study intends to conduct a multicenter, non-inferior randomized controlled clinical trial to compare the effectiveness and safety of trabeculectomy versus SPI+GSL+GT in advanced PACG with no or mild cataracts.

Official Title
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Effectiveness and Safety of Trabeculectomy and Peripheral Iridectomy Plus Goniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Non-inferiority Randomized Controlled Trial

Conditions
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Primary Angle Closure Glaucoma

Intervention / Treatment
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* Procedure: Trabeculectomy
* Procedure: SPI+GSL+GT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 45-80 years. Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b, and d: PAS: ≥180° range, including nasal and inferior quadrants; IOP >21 mmHg with or without anti-glaucoma medications (the medications include the maximally tolerated medications), taken with the Goldmann applanation tonometer; Glaucomatous optic neuropathy (cup-to-disc [C/D] ratio ≥0.7, C/D asymmetry >0.2, or rim width at the superior and inferior temporal areas <0.1 of the vertical diameters of the optic disc); Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB). No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Diabetic Retinopathy Study chart); Axial length of ≥20 mm. Exclusion Criteria: History of ocular surgery or trauma. Retinal disease that influences the collection of ocular parameters or other types of glaucoma, including open-angle glaucoma, secondary angle-closure glaucoma, steroidal glaucoma, angle recession glaucoma, neovascular glaucoma, nanophthalmos, and pseudoexfoliation syndrome. Monophthalmia (best-corrected visual acuity of <0.01 in the non-study eye). An International Standardized Ratio of >3.0, for patients receiving warfarin or anticoagulant therapy before surgery. Patients with serious systemic diseases. Pregnant or lactating women. If both eyes are eligible for the study, the eye with the worse visual field or optic nerve will be included.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicenter, parallel, open, non-inferior randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Trabeculectomy<br>Forty-four patients with advanced primary angle closure glaucoma will receive trabeculectomy. | Procedure: Trabeculectomy<br>* trabeculectomy<br>|
| Experimental: SPI+GSL+GT<br>Forty-four patients with advanced primary angle closure glaucoma will receive surgical peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT). | Procedure: SPI+GSL+GT<br>* Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure at postoperative 12 months | Intraocular pressure after surgery using Goldmann or non-contact tonometer. | Postoperative 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative success rate of surgery | Cumulative success rate of surgery is defined as : (i) Complete success is defined as the postoperative intraocular pressure between 5 and 18 mmHg, and 20% reduction from baseline without anti-glaucoma medications. (ii) Qualified success is defined as the postoperative intraocular pressure between 5 and 18 mmHg, and 20% reduction from baseline with anti-glaucoma medications. | Postoperative 12, 24, 36 months | 
| Intraoperative and postoperative complications | Intraoperative and postoperative complications, such as shallow anterior chamber, malignant glaucoma, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and bleb-related complications. | Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months | 
| The numbers of anti-glaucoma medications | Numbers of anti-glaucoma medications. | Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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angle closure, glaucoma