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

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

Study Overview

• Status: Recruiting
• Conditions: Primary Open Angle Glaucoma and Cataracts
• Intervention / Treatment: Combination product: PEI combined with gonioscopy-assisted trabeculotomy; Combination product: PEI combined with conventional topical IOP-lowering medications

Detailed Description

Primary open-angle glaucoma is a chronic progressive optic neuropathy in which sustained intraocular pressure control is important for delaying structural and functional progression. Long-term topical IOP-lowering medication may be limited by ocular surface disease, poor adherence, treatment cost, and cumulative ocular tissue exposure. Gonioscopy-assisted trabeculotomy is an ab interno minimally invasive glaucoma procedure that can be combined with phacoemulsification in patients with coexisting cataract. This trial will compare PEI plus GT with PEI plus conventional medications as an initial treatment strategy in treatment-naive patients with POAG and cataract. Randomization will be stratified by center and implemented through an IWRS or equivalent web-based randomization system. Outcome assessors will be masked whenever feasible. Follow-up visits are scheduled at Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24.

• Study Type: Interventional
• Enrollment (Estimated): 106
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hongyang Zhang, PhD; Phone Number: +86-20-62787325; Email: hy3005716@163.com
• Study Contact Backup: Name: Yuqiao Zhang, PhD; Email: yqzhang@link.cuhk.edu.hk

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • Nanfang Hospital, Southern Medical University
    • Contact: Hongyang Zhang; Phone Number: +86-20-62787325; Email: hy3005716@163.com
  • Luzhou, China
    • Not yet recruiting
    • The Affiliated Hospital of Southwest Medical University
  • Zhengzhou, China
    • Not yet recruiting
    • The First Affiliated Hospital of Zhengzhou University
    • Contact: Xin Yang
  • Zhuhai, China
    • Not yet recruiting
    • Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine
  • Ningxia
    • Ningxia, Ningxia, China
      • Not yet recruiting
      • People's Hospital of Ningxia Hui Autonomous Region

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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, 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.
• Pregnancy, lactation, or planned pregnancy during the study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEI combined with gonioscopy-assisted trabeculotomy; Participants will undergo phacoemulsification cataract extraction with intraocular lens implantation combined with approximately 120 degrees of ab interno gonioscopy-assisted trabeculotomy during the same surgical session. Postoperative care will follow the protocol, and rescue IOP-lowering medications may be added if clinically indicated.	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.
Active Comparator: PEI combined with conventional IOP-lowering medications; Participants will undergo phacoemulsification cataract extraction with intraocular lens implantation. Postoperatively, conventional topical IOP-lowering medications will be initiated or adjusted according to guideline-based care and clinical judgment when IOP remains above target.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in intraocular pressure from baseline to Month 24	Intraocular pressure will be measured in mmHg, preferably by Goldmann applanation tonometry. Change will be calculated as Month 24 IOP minus baseline IOP and compared between groups.	Baseline and Month 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete success rate	Proportion of participants achieving postoperative IOP >5 mmHg and ≤16 mmHg or at least 20 percent IOP reduction from baseline, without additional IOP-lowering medication, without vision-threatening complication, and without additional glaucoma surgery.	Month 24
Qualified success rate	Proportion of participants achieving postoperative IOP >5 mmHg and ≤16 mmHg or at least 20 percent IOP reduction from baseline, with or without IOP-lowering medication, without vision-threatening complication, and without additional glaucoma surgery.	Month 24
Number of IOP-lowering medications	Number and class of topical IOP-lowering medications used at each follow-up visit.	Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
Best-corrected visual acuity	Best-corrected visual acuity will be recorded and converted to LogMAR for analysis.	Baseline through Month 24
Visual field indices	Humphrey visual field 30-2 SITA Standard indices, including mean deviation and pattern standard deviation, will be recorded with reliability criteria.	Baseline, Month 6, Month 12, Month 18, and Month 24
Retinal nerve fiber layer thickness	Peripapillary retinal nerve fiber layer thickness will be measured by OCT.	Baseline, Month 6, Month 12, Month 18, and Month 24
Ganglion cell-inner plexiform layer thickness	Macular ganglion cell-inner plexiform layer thickness will be measured by OCT.	Baseline, Month 6, Month 12, Month 18, and Month 24
Anterior segment parameters by AS-OCT	AS-OCT parameters may include anterior chamber depth, angle opening distance, trabecular-iris space area, and other protocol-specified anterior segment findings.	Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
Ocular surface parameters	Ocular surface assessment includes lipid layer thickness, tear meniscus height, non-invasive tear break-up time, meibomian gland structure, conjunctival hyperemia, and corneal fluorescein staining.	Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
NEI VFQ-25 score	Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25 total score.	Baseline, Month 6, Month 12, Month 18, and Month 24
GAD-7 score	Anxiety will be assessed using the Generalized Anxiety Disorder 7-item scale total score.	Baseline, Month 6, Month 12, Month 18, and Month 24
Incidence of adverse events	Ocular and systemic adverse events and serious adverse events will be recorded, including IOP spike, hypotony, hyphema, corneal edema, anterior chamber inflammation, posterior capsule opacification, infection, and need for additional glaucoma surgery.	Day 1 through Month 24
Health economic indicators	Direct medical costs, medication costs, follow-up costs, complication management costs, and other prespecified economic cost indicators will be summarized.	Baseline through Month 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tear-fluid biomarker levels	Tear-fluid biomarkers include matrix metalloproteinase (MMP), interleukin-13 (IL-13), and tumor necrosis factor-alpha (TNF-alpha).	Baseline and Month 24
Surgery-drug benefit index	Composite exploratory index integrating IOP control, medication reduction, structural preservation, ocular surface status, quality of life, safety, and economic outcomes.	Baseline through Month 24

Collaborators and Investigators

• Sponsor: Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Ocular Hypertension; Glaucoma; Cataract; Glaucoma, Open-Angle
• Other Study ID Numbers: NFEC-2026-303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No