NCT04878458

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

Effectiveness and Safety of Phacotrabeculectomy and Phacogoniotomy in Advanced Primary Angle-closure Glaucoma: a Multicenter Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Glaucoma, Angle-Closure

Interventions

Type	Name	Description
PROCEDURE	phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy	The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.
PROCEDURE	phacoemulsification with intraocular lens implantation combined with trabeculectomy	The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with trabeculectomy.

Timeline

• Start date: 2021-05-31
• Primary completion: 2023-05-30
• Completion: 2025-06-30
• First posted: 2021-05-07
• Last updated: 2024-12-11

Locations

2 sites across 1 country: China