Evaluation of Phacogoniotomy in Medically-controlled POAG — ECO  

Glaucoma, Open-Angle Clinical Trial

Official title: Efficacy of Phacogoniotomy in Medically-controlled Primary Open-angle Glaucoma With Cataract a Multicenter Non-inferiority Randomized Controlled Trial

Status Recruiting

Clinical Trial Summary

The goal of this multicenter non-inferiority randomized controlled trial is to compare the efficacy of phacoemulsification with intraocular lens implantation (PEI) combined with goniotomy (GT) and PEI combined with medical therapy (MED) in the treatment of medically-controlled primary open-angle glaucoma (POAG) with cataract. The main questions it aims to answer are: - Whether the PEI+GT was non-inferior to PEI+MED with regard to the intraocular pressure lowering effect in medically-controlled POAG. - Whether the PEI+GT has value of health economics. Participants will be randomized to receive either PEI+GT or PEI+MED, and followed up with a 1-year period as a primary outcome.

Clinical Trial Description

Glaucoma is the leading cause of irreversible blindness worldwide, with primary open-angle glaucoma (POAG) remaining the most common subtype. Although there are various methods to treat POAG, medication remains the first choice. However, medication therapy has several limitations, such as multiple adverse effects, poor compliance, and high costs. Therefore, it is imperative to explore treatment modalities that reduce medication burden and improve patients' quality of life. Minimally invasive glaucoma surgery (MIGS) has been widely employed in clinical practice in recent years and become the mainstream surgical approach for POAG treatment. Among them, various forms of Schlemm's canal-based procedures, which were commonly known as ab interno trabeculotomy or goniotomy (GT) have garnered clinical significance due to their advantages of simplicity, minimal invasiveness, low complication rates, and rapid recovery. These procedures can also be combined with phacoemulsification with intraocular lens implantation (PEI). Currently, several GT techniques have been reported using different devices with different ranges of incision. The investigators have proved that a 120-degree GT with or with PEI were effective enough to treat patients with POAG with or without cataract, providing a comparable efficacy with 240 or 360 degree GT. The 120-degree is characterized by not only its efficacy, but also its fewer complications, faster procedure and quicker recovery. Although the techniques have been implemented clinically, further research is needed to evaluate their economics value in terms of reducing patient dependence on medication, relieving the economic burden of glaucoma medications, and improving the quality of life. Therefore, a non-inferiority randomized controlled trial (RCT) will be conducted in medically controlled POAG patients with cataract, comparing PEI+GT to PEI combined with medication therapy (PEI+MED). The trial aims to validate the effectiveness of GT in reducing medication use, lightening the burden on patients, and providing a novel treatment approach. ;

Related Conditions & MeSH terms

• Cataract
• Glaucoma
• Glaucoma, Open-Angle

• NCT number: NCT06201455
• Study type: Interventional
• Source: Sun Yat-sen University
• Contact: Xiulan Zhang, MD. PhD
• Phone: +86 13570166308
• Email: zhangxl2@mail.sysu.edu.cn
• Status: Recruiting
• Phase: N/A
• Start date: September 28, 2023
• Completion date: December 31, 2029