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

NCT07700498 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2026-07-14

No results posted yet for this study

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

Conditions

  • Primary Open Angle Glaucoma and Cataracts

Interventions

COMBINATION_PRODUCT

PEI 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_PRODUCT

PEI 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.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-15
Primary Completion
2029-12-31
Completion
2030-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07700498 on ClinicalTrials.gov