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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 5
- 主要终点
- Mean change in intraocular pressure from baseline to Month 24
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: PEI combined with conventional topical IOP-lowering medications (Combination Product)
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.
干预措施: PEI combined with gonioscopy-assisted trabeculotomy (Combination Product)
结局指标
主要结局
Mean change in intraocular pressure from baseline to Month 24
时间窗: 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.
次要结局
- Complete success rate(Month 24)
- Qualified success rate(Month 24)
- Number of IOP-lowering medications(Baseline, Day 1, Day 7, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24)
- Best-corrected visual acuity(Baseline through Month 24)
- Visual field indices(Baseline, Month 6, Month 12, Month 18, and Month 24)
- Retinal nerve fiber layer thickness(Baseline, Month 6, Month 12, Month 18, and Month 24)
- Ganglion cell-inner plexiform layer thickness(Baseline, Month 6, Month 12, Month 18, and Month 24)
- Anterior segment parameters by AS-OCT(Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24)
- Ocular surface parameters(Baseline, Month 1, Month 3, Month 6, Month 9, Month 12, Month 18, and Month 24)
- NEI VFQ-25 score(Baseline, Month 6, Month 12, Month 18, and Month 24)
- GAD-7 score(Baseline, Month 6, Month 12, Month 18, and Month 24)
- Incidence of adverse events(Day 1 through Month 24)
- Health economic indicators(Baseline through Month 24)