Evaluation of Phacogoniotomy in Medically-controlled POAG

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.

Conditions

• Glaucoma, Open-Angle
• Cataract Complicated
• Goniotomy

Interventions

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.

Sponsors & Collaborators

• West China Hospital

  collaborator OTHER

• Chongqing Medical University

  collaborator OTHER

• The Second Hospital of Anhui Medical University

  collaborator OTHER

• Handan City Eye Hospital

  collaborator UNKNOWN

• Shijiazhuang People's Hospital

  collaborator OTHER

• Chengdu First People's Hospital

  collaborator OTHER

• Guangdong Hospital of Traditional Chinese Medicine, Zhuhai

  collaborator UNKNOWN

• Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

  collaborator OTHER

• Huizhou Municipal Central Hospital

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-28

Primary Completion

2026-09-30

Completion

2029-12-31

Countries

• China

Study Locations