NCT07700498Recruiting
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
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 106 (estimated)
- First submitted
- 7 Jul 2026
- Start date
- 15 Jul 2026
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Glaucoma
- NCT number
- NCT07700498
What you commit to
- Study type: Interventional
- Planned participants: 106
- From 15 Jul 2026 to the primary completion date, 31 Dec 2029
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Secondary glaucoma, including uveitic, pseudoexfoliative, pigmentary, steroid-induced, neovascular, traumatic, or other secondary glaucoma.
- Previous anti-glaucoma medication use, glaucoma surgery, or glaucoma laser treatment.
- Known contraindication to required study medications.
Other illness
- Systemic disease that may affect ocular status or study assessment, including diabetes mellitus, uncontrolled hypertension, malignancy, renal disease, autoimmune disease, neurological disease, liver disease, cardiovascular disease, or systemic inflammatory disease.
- Visual impairment mainly attributable to disease other than POAG or cataract.
Other
- Angle-closure glaucoma or narrow angle inconsistent with POAG.
- POAG without visually significant cataract.
- 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.
- 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.
- Pregnancy, lactation, or planned pregnancy during the study period.
Who the study is looking for
- 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.
Age in the registry: 40 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| The Affiliated Hospital of Southwest Medical University Coordinator of this site? Confirm its status | Luzhou | China | Not yet recruiting |
| People's Hospital of Ningxia Hui Autonomous Region Coordinator of this site? Confirm its status | Ningxia | China | Not yet recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine Coordinator of this site? Confirm its status | Zhuhai | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.