RecruitingNot ApplicableNCT06201455

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

Sponsor

Sun Yat-sen University

Enrollment

100 participants

Start Date

Sep 28, 2023

Study Type

INTERVENTIONAL

Conditions

Glaucoma, Open-Angle Cataract Complicated Goniotomy

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.

Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This trial evaluates a combined surgical procedure called phacogoniotomy — cataract removal plus a procedure to improve fluid drainage from the eye — in people with open-angle glaucoma (a condition causing increased eye pressure that can damage vision) whose pressure is already controlled with eye drops. **You may be eligible if...** - You are between 40 and 85 years old - You have been diagnosed with open-angle glaucoma - Your eye pressure is controlled (24 mmHg or below) with 1–4 eye drops - You also have a visually significant cataract (cloudy lens) - Your vision loss from glaucoma is not too advanced **You may NOT be eligible if...** - You have had any prior eye surgery or serious eye injury - You have a different type of glaucoma (such as closed-angle, steroid-induced, or neovascular glaucoma) - Your eye is longer than 28 mm (very nearsighted) - You only have useful vision in one eye - You are pregnant or breastfeeding - You have a severe systemic illness Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREPEI+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).

PROCEDUREPEI+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.

Locations(1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT06201455

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