NCT06201455

Evaluation of Phacogoniotomy in Medically-controlled POAG

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 40 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Glaucoma, Open-Angle
• Cataract Complicated
• Goniotomy

Interventions

Type	Name	Description
PROCEDURE	PEI+GT	After a standard phacoemulsification with intraocular lens implantation (PEI) is performed. The viscoelastic substance will be injected into the anterior chamber again to maintain corneal rigidity. The surgical microscope will be adjusted to tilt 35-40° towards the patient's nasal side, and the patient's head position will be adjusted to tilt 35-40° accordingly. A viscoelastic substance will be applied to the corneal surface to facilitate direct visualization of the angle structures under a gonioscope. The Tanito Microhook will be inserted through the main incision into the anterior chamber, and under gonioscopic guidance, the nasal (or inferonasal) trabecular meshwork and the inner wall of Schlemm's canal will be incised, approximately 120° in extent (60° in each direction).
PROCEDURE	PEI+MED	Participants assigned to control group will undergo routine PEI surgery. Postoperatively, the decision to administer anti-glaucoma medication is based on intraocular pressure (IOP) measurements, and the target IOP is set at 16 mmHg. The selection of medications is informed by the Asia Pacific Glaucoma Guidelines (Kugler Publications, 2016), while the target IOP reference is the European Glaucoma Guidelines.

Timeline

• Start date: 2023-09-28
• Primary completion: 2026-09-30
• Completion: 2029-12-31
• First posted: 2024-01-11
• Last updated: 2024-12-11

Locations

1 site across 1 country: China