Phacotrabeculectomy Versus Phacogoniotomy (PVP) in Advanced Primary Angle-closure Glaucoma

Not Applicable

Active, not recruiting

• Conditions: Glaucoma, Angle-Closure
• Interventions: Procedure: phacoemulsification with intraocular lens implantation combined with trabeculectomy; Procedure: phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy

• Registration Number: NCT04878458
• Lead Sponsor: Sun Yat-sen University

Brief Summary

A multicenter, parallel, open, non-inferior randomized controlled trial was conducted to compare the effectiveness and safety of phacotrabeculectomy and phacogoniotomy in the treatment of advanced primary angle closure glaucoma, so as to provide a better surgical alternative.

Detailed Description

Glaucoma is the leading cause of irreversible blindness worldwide, and primary angle closure glaucoma (PACG) accounted for the majority particularly in Asia and China. The preferred treatment method is anti-glaucoma surgery-trabeculectomy (Trab) combined with lens extraction. Phacotrabeculectomy has become the first-line choice of anti-glaucoma suregery in the treatment of advanced PACG. However, it was not an ideal method due to the bleb-related complications and troublesome postoperative nursing, as well as the difficulty for surgeons, caused by trabeculectomy. However, recent studies revealed that the phacoemulsification with intraocular lens implantation (PEI) combined with goniosynechialysis (GSL) has achieved efficacy in the treatment of PACG.

With the advent of minimally invasive glaucoma surgeries (MIGS), there is an increasing number studies indicating the MIGS performed great efficacy in the treatment of primary open angle glaucoma. While,there were a few small-sampled retrospective studies which showed therapeutic effects in PACG. The GSL plus goniotomy (GT) could achieve great efficacy in lowering the intraocular pressure of PACG patients. However, there is still a lack of high quality and high-level randomized controlled trials.

Therefore, this study intends to conduct a multicenter, parallel, open, non-inferior randomized controlled trial to compare the effectiveness and safety of PEI+ Trab and PEI+GSL+GT in the treatment of advanced PACG, so as to provide a better surgical treatment for PACG.

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-06
• Study First Posted: 2021-05-07
• Study Start: 2021-05-31
• Primary Completion: 2023-05-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PEI+Trab	phacoemulsification with intraocular lens implantation combined with trabeculectomy	Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with trabeculectomy.
PEI+GSL+GT	phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy	Sixty-two patients with advanced primary angle-closure glaucoma will receive phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.

Primary Outcome Measures

Name	Time	Method
Mean change of intraocular pressure	Postoperative 12, 24, 36 months.	Change from baseline IOP after surgery using Goldmann or non-contact tonometer.

Secondary Outcome Measures

Name	Time	Method
Intraoperative and postoperative complications	0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months	For example, shallow anterior chamber, hyphema, persistent hypotony, corneal endothelium decompensation, endophthalmitis, and other filtering bleb-related complications.
Anti-glaucomatous medications	0, 1, 7 day. 1, 3, 6, 12, 18, 24, 30, 36 months	Numbers and types of anti-glaucomatous medications
Cumulative success rate of surgery	12, 24, 36 months	(i) Complete success is defined as the postoperative IOP between 5 and 18 mmHg, and 20% reduction from baseline with no need for IOP-lowering medication.; (ii) Qualified success is defined as the postoperative IOP between 5 and 18 mmHg, and 20% reduction from baseline with or without IOP-lowering medication.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center; 🇨🇳 Guangdong, China