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

RecruitingNAAges 40 Years - 85 YearsAllNanfang Hospital, Southern Medical University
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In plain words

What the trial is, and whether it could suit you

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 w

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

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

5 sites
People's Hospital of Ningxia Hui Autonomous Region
Ningxia, China
Nanfang Hospital, Southern Medical University
Guangzhou, China
The Affiliated Hospital of Southwest Medical University
Luzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine
Zhuhai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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