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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-85
SponsorNanfang Hospital, Southern Medical University

About this 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

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • PEI combined with gonioscopy-assisted trabeculotomy
  • PEI combined with conventional topical IOP-lowering medications

Treatment groups

106 Participants
are divided into 2 treatment groups