RecruitingNot Applicable

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

China106 participantsStarted 2026-07-15

Plain-language 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

Who can participate

Age range

40 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Provides written informed consent voluntarily. * Age 40 to 85 years. * Male or female. * Treatment-naive for glaucoma, with no prior IOP-lowering medication, glaucoma laser procedure, or glaucoma surgery. * Lens opacity causing decreased visual quality and clinically significant cataract. * Diagnosis of POAG combined with cataract by the treating ophthalmologist. * Best-corrected visual acuity of 0.1 or better on the Snellen chart, corresponding to LogMAR 1.0 or less. * Ability and willingness to complete scheduled follow-up visits and study examinations. Exclusion Criteria: * Secondary glaucoma, including uveitic, pseudoexfoliative, pigmentary, steroid-induced, neovascular, traumatic, or other secondary glaucoma. * Angle-closure glaucoma or narrow angle inconsistent with POAG. * POAG without visually significant cataract. * Previous anti-glaucoma medication use, glaucoma surgery, or glaucoma laser treatment. * Advanced visual field loss, defined as visual field mean deviation worse than -12 dB. * Severe ocular comorbidity or inability to perform reliable visual acuity testing. * Known contraindication to required study medications. * Average RNFL thickness or GCIPL thickness less than 54 micrometers. * Axial length greater than 26 mm. * Monocular status or functional vision in only one eye. * Inability to complete reliable visual field or OCT testing. * Systemic disease that may affect ocular status or study assessment, including diabetes mellitus, u…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is listed as Phase 'NA' rather than a standard Phase 1, 2, or 3 — what does that mean for how much is already known about the safety and effectiveness of the treatment being studied here?
2The trial measures changes in eye pressure over 24 months, which means I'd need to commit to follow-up visits for at least two years — is that level of time and scheduling realistic given my current situation, and what happens to my care if I need to drop out early?
3Since this trial targets people who have both glaucoma and cataracts at the same time, how does the approach being studied here compare to what you'd normally recommend for treating my cataract and glaucoma separately or together outside of a trial?
4If my eye pressure isn't well controlled during the 24-month study period, would I still be able to receive additional or rescue treatments, or would participating in this trial limit my options in the meantime?
5Before considering this trial, is there a standard treatment path you'd recommend first for someone with my specific combination of open-angle glaucoma and cataracts, and how would trying that first affect whether I could still enroll later?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mean change in intraocular pressure from baseline to Month 24

Timeframe: Baseline and Month 24

Trial details

NCT IDNCT07700498

SponsorNanfang Hospital, Southern Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Hongyang Zhang, PhD

+86-20-62787325 hy3005716@163.com

View on ClinicalTrials.gov More Primary Open Angle Glaucoma and Cataracts trials