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

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.

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.