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

2026年7月7日 更新者：Nanfang Hospital, Southern Medical University

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

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

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

106

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Hongyang Zhang, PhD
  • 电话号码：+86-20-62787325
  • 邮箱：hy3005716@163.com

研究联系人备份

学习地点

  • 中国
      • Guangzhou、中国
        • 招聘中
        • Nanfang Hospital, Southern Medical University
        • 接触：
      • Luzhou、中国
        • 尚未招聘
        • The Affiliated Hospital of Southwest Medical University
      • Zhengzhou、中国
        • 尚未招聘
        • The First Affiliated Hospital of Zhengzhou University
        • 接触：
          • Xin Yang
      • Zhuhai、中国
        • 尚未招聘
        • Zhuhai Hospital of Guangdong Provincial Hospital of Chinese Medicine
    • Ningxia
      • Ningxia、Ningxia、中国
        • 尚未招聘
        • People's Hospital of Ningxia Hui Autonomous Region

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：PEI combined with gonioscopy-assisted trabeculotomy
Participants will undergo phacoemulsification cataract extraction with intraocular lens implantation combined with approximately 120 degrees of ab interno gonioscopy-assisted trabeculotomy during the same surgical session. Postoperative care will follow the protocol, and rescue IOP-lowering medications may be added if clinically indicated.
组合产品：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.
有源比较器：PEI combined with conventional IOP-lowering medications
Participants will undergo phacoemulsification cataract extraction with intraocular lens implantation. Postoperatively, conventional topical IOP-lowering medications will be initiated or adjusted according to guideline-based care and clinical judgment when IOP remains above target.
组合产品：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Mean change in intraocular pressure from baseline to Month 24
大体时间：Baseline and Month 24
Intraocular pressure will be measured in mmHg, preferably by Goldmann applanation tonometry. Change will be calculated as Month 24 IOP minus baseline IOP and compared between groups.
Baseline and Month 24

次要结果测量

结果测量
措施说明
大体时间
Complete success rate
大体时间：Month 24
Proportion of participants achieving postoperative IOP >5 mmHg and ≤16 mmHg or at least 20 percent IOP reduction from baseline, without additional IOP-lowering medication, without vision-threatening complication, and without additional glaucoma surgery.
Month 24
Qualified success rate
大体时间：Month 24
Proportion of participants achieving postoperative IOP >5 mmHg and ≤16 mmHg or at least 20 percent IOP reduction from baseline, with or without IOP-lowering medication, without vision-threatening complication, and without additional glaucoma surgery.
Month 24
Number of IOP-lowering medications
大体时间：Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
Number and class of topical IOP-lowering medications used at each follow-up visit.
Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
Best-corrected visual acuity
大体时间：Baseline through Month 24
Best-corrected visual acuity will be recorded and converted to LogMAR for analysis.
Baseline through Month 24
Visual field indices
大体时间：Baseline, Month 6, Month 12, Month 18, and Month 24
Humphrey visual field 30-2 SITA Standard indices, including mean deviation and pattern standard deviation, will be recorded with reliability criteria.
Baseline, Month 6, Month 12, Month 18, and Month 24
Retinal nerve fiber layer thickness
大体时间：Baseline, Month 6, Month 12, Month 18, and Month 24
Peripapillary retinal nerve fiber layer thickness will be measured by OCT.
Baseline, Month 6, Month 12, Month 18, and Month 24
Ganglion cell-inner plexiform layer thickness
大体时间：Baseline, Month 6, Month 12, Month 18, and Month 24
Macular ganglion cell-inner plexiform layer thickness will be measured by OCT.
Baseline, Month 6, Month 12, Month 18, and Month 24
Anterior segment parameters by AS-OCT
大体时间：Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
AS-OCT parameters may include anterior chamber depth, angle opening distance, trabecular-iris space area, and other protocol-specified anterior segment findings.
Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
Ocular surface parameters
大体时间：Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
Ocular surface assessment includes lipid layer thickness, tear meniscus height, non-invasive tear break-up time, meibomian gland structure, conjunctival hyperemia, and corneal fluorescein staining.
Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24
NEI VFQ-25 score
大体时间：Baseline, Month 6, Month 12, Month 18, and Month 24
Vision-related quality of life will be assessed using the National Eye Institute Visual Function Questionnaire-25 total score.
Baseline, Month 6, Month 12, Month 18, and Month 24
GAD-7 score
大体时间：Baseline, Month 6, Month 12, Month 18, and Month 24
Anxiety will be assessed using the Generalized Anxiety Disorder 7-item scale total score.
Baseline, Month 6, Month 12, Month 18, and Month 24
Incidence of adverse events
大体时间：Day 1 through Month 24
Ocular and systemic adverse events and serious adverse events will be recorded, including IOP spike, hypotony, hyphema, corneal edema, anterior chamber inflammation, posterior capsule opacification, infection, and need for additional glaucoma surgery.
Day 1 through Month 24
Health economic indicators
大体时间：Baseline through Month 24
Direct medical costs, medication costs, follow-up costs, complication management costs, and other prespecified economic cost indicators will be summarized.
Baseline through Month 24

其他结果措施

结果测量
措施说明
大体时间
Tear-fluid biomarker levels
大体时间：Baseline and Month 24
Tear-fluid biomarkers include matrix metalloproteinase (MMP), interleukin-13 (IL-13), and tumor necrosis factor-alpha (TNF-alpha).
Baseline and Month 24
Surgery-drug benefit index
大体时间：Baseline through Month 24
Composite exploratory index integrating IOP control, medication reduction, structural preservation, ocular surface status, quality of life, safety, and economic outcomes.
Baseline through Month 24

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Nanfang Hospital, Southern Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月15日

初级完成 (估计的)

2029年12月31日

研究完成 (估计的)

2030年12月31日

研究注册日期

首次提交

2026年7月7日

首先提交符合 QC 标准的

2026年7月7日

首次发布 (实际的)

2026年7月14日

研究记录更新

最后更新发布 (实际的)

2026年7月14日

上次提交的符合 QC 标准的更新

2026年7月7日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • NFEC-2026-303

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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