Early Combined Cataract Surgery and Gonioscopy-Assisted Trabeculotomy Versus Cataract Surgery with Medications for Adults With Primary Open-Angle Glaucoma and Cataract

What this Trial Is About

Researchers are studying whether combining phacoemulsification cataract surgery with gonioscopy-assisted trabeculotomy as an initial treatment can reduce the need for long-term glaucoma eye drops in adults with primary open-angle glaucoma and cataract. This trial also aims to assess if this early surgical approach improves the health of the eye surface and quality of life related to vision and anxiety compared to cataract surgery followed by standard glaucoma medications. The study compares these two treatment strategies in patients who have not previously been treated for glaucoma. Participants will be randomly assigned to one of two groups. One group will have cataract surgery combined with about 120 degrees of ab interno gonioscopy-assisted trabeculotomy using a non-device-dependent cutting tool during the same surgery. The other group will have cataract surgery followed by guideline-based topical eye pressure-lowering medications such as prostaglandin analogues and others as needed. Follow-up visits are scheduled over 24 months to monitor outcomes. During the study, participants will attend visits at specific times including Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24. They will undergo eye pressure checks, vision tests, OCT scans, anterior segment OCT, visual field tests, ocular surface examinations, and safety evaluations. They will also complete questionnaires about quality of life and anxiety, and provide tear samples for biomarker testing. Researchers will measure changes in eye pressure, success rates, medication use, vision quality, retinal nerve and ganglion cell layer thickness, ocular surface health, adverse events, and economic indicators.

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