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

Official title

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

Overview

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

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.

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.

Primary outcome measures

• Mean change in intraocular pressure from baseline to Month 24 [Time frame: Baseline and Month 24]

Secondary outcome measures (12)

• Complete success rate [Time frame: Month 24]
• Qualified success rate [Time frame: Month 24]
• Number of IOP-lowering medications [Time frame: Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24]
• Best-corrected visual acuity [Time frame: Baseline through Month 24]
• Visual field indices [Time frame: Baseline, Month 6, Month 12, Month 18, and Month 24]
• Retinal nerve fiber layer thickness [Time frame: Baseline, Month 6, Month 12, Month 18, and Month 24]
• Ganglion cell-inner plexiform layer thickness [Time frame: Baseline, Month 6, Month 12, Month 18, and Month 24]
• Anterior segment parameters by AS-OCT [Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24]
• Ocular surface parameters [Time frame: Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24]
• NEI VFQ-25 score [Time frame: Baseline, Month 6, Month 12, Month 18, and Month 24]
• GAD-7 score [Time frame: Baseline, Month 6, Month 12, Month 18, and Month 24]
• Incidence of adverse events [Time frame: Day 1 through Month 24]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

China · 5 centers

• People's Hospital of Ningxia Hui Autonomous Region — Ningxia
• Nanfang Hospital, Southern Medical University — Guangzhou
• The Affiliated Hospital of Southwest Medical University — Luzhou
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou
• Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine — Zhuhai

Identifiers

NCT: NCT07700498 · NFEC-2026-303

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗