RecruitingNot ApplicableNCT07700498

PEI-GT Trial for Initial Treatment of Primary Open-Angle Glaucoma With Cataract

Efficacy and Safety of Phacoemulsification Combined With Gonioscopy-Assisted Trabeculotomy as Initial Treatment for Primary Open-Angle Glaucoma With Cataract: A Multicenter Randomized Controlled Trial


Sponsor

Nanfang Hospital, Southern Medical University

Enrollment

106 participants

Start Date

Jul 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn whether doing phacoemulsification combined with gonioscopy-assisted trabeculotomy as an initial treatment can reduce the burden of glaucoma eye drops in adults with primary open-angle glaucoma and cataract. It will also learn whether this early surgical strategy improves ocular surface health and vision-related quality of life. The main questions it aims to answer are: Does early combined surgery reduce the need for long-term glaucoma medications? Does early combined surgery improve ocular surface health compared with cataract surgery followed by guideline-based glaucoma eye drops? Does early combined surgery improve vision-related quality of life and anxiety compared with the medication-based treatment strategy? What medical problems or complications do participants have after treatment? Researchers will compare phacoemulsification combined with gonioscopy-assisted trabeculotomy to phacoemulsification followed by guideline-based topical eye pressure-lowering medications. Participants will: Undergo cataract surgery with or without gonioscopy-assisted trabeculotomy Attend follow-up visits for 24 months after treatment Have eye pressure, visual acuity, OCT, AS-OCT, visual field, ocular surface, and safety examinations at scheduled visits Complete quality-of-life and anxiety questionnaires at scheduled visits Provide tear samples at selected visits for biomarker testing where applicable


Eligibility

Min Age: 40 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying PEI combined with conventional topical IOP-lowering medications and PEI combined with gonioscopy-assisted trabeculotomy for people with primary open angle glaucoma and cataracts. The study is currently recruiting participants at 5 locations.

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

COMBINATION_PRODUCTPEI combined with gonioscopy-assisted trabeculotomy

Phacoemulsification combined with Ab interno trabeculotomy performed under gonioscopic visualization for approximately 120 degrees to incise/open the trabecular meshwork and expose Schlemm canal. The cutting instrument will be non-device-dependent, such as a Tanito hook, Lanxin knife, Zeng knife, or bent 25-26G needle; KDB is not included as the cutting blade.

COMBINATION_PRODUCTPEI combined with conventional topical IOP-lowering medications

Phacoemulsification combined with guideline-based topical IOP-lowering therapy, generally including prostaglandin analogues unless contraindicated, with beta-blockers, carbonic anhydrase inhibitors, alpha-2 agonists, or other agents added or adjusted according to efficacy, tolerance, contraindications, and clinical judgment.


Locations(5)

People's Hospital of Ningxia Hui Autonomous Region

Ningxia, Ningxia, China

Nanfang Hospital, Southern Medical University

Guangzhou, China

The Affiliated Hospital of Southwest Medical University

Luzhou, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine

Zhuhai, China

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NCT07700498