Trabeculectomy Versus Peripheral Iridectomy Plus Goniotomy in Advanced PACG

Sun Yat-sen University88 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Primary Angle Closure Glaucoma

Interventions

TrabeculectomyPROCEDURE

trabeculectomy

SPI+GSL+GTPROCEDURE

Peripheral iridectomy (SPI) combined with goniosynechialysis (GSL) and goniotomy (GT)

Eligibility

Sex: ALLMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 45-80 years. 2. Eyes diagnosed with advanced PACG who meet following criteria a, b, and c; or a, b, and d: 1. PAS: ≥180° range, including nasal and inferior quadrants; 2. IOP \>21 mmHg with or without anti-glaucoma medications (the medications include the maximally tolerated medications), taken with the Goldmann applanation tonometer; 3. 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); 4. Glaucomatous visual field defects (nasal step, arcuate scotoma, and paracentral scotoma on a reliable Humphrey analyzer and a mean deviation of ≤-12 dB). 3. No or mild cataracts and uncorrected visual acuity of ≥0.63 (Early Treatment Diabetic Retinopathy Study chart); 4. Axial length of ≥20 mm. Exclusion Criteria: 1. History of ocular surgery or trauma. 2. 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. 3. Monophthalmia (best-corrected visual acuity of \<0.01 in the non-study eye). 4. An International Standardized Ratio of \>3.0, for patients receiving warfarin or anticoagulant therapy before surgery. 5. Patients with serious systemic diseases. 6. 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.

Locations (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Intraocular pressure at postoperative 12 months

Intraocular pressure after surgery using Goldmann or non-contact tonometer.

Time frame: Postoperative 12 month

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Postoperative 0, 1, 7 days, and 1, 3, 6, 12, 18, 24, 30, 36 months

Central Contacts

Xiulan Zhang, MD. PhD

CONTACT

+86 13570166308 zhangxl2@mail.sysu.edu.cn

Xinbo Gao, MD. PhD

CONTACT

+86 18319579657 gaoxb@mail.sysu.edu.cn

Data from ClinicalTrials.gov

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