Integrated Chemical and Proteomic Analysis of Aqueous Humor and Ocular Tissues in Glaucoma and Cataract Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- IOP
研究概览
简要总结
This observational study will compare proteomic and elemental profiles of aqueous humor and ocular tissues in patients with primary open-angle glaucoma (POAG) and cataract versus cataract controls without glaucoma. Samples collected during standard surgery will be analyzed using LC-MS/MS and ICP-MS. The goal is to identify glaucoma-associated molecular patterns with potential diagnostic or prognostic relevance.
详细描述
This observational study will evaluate molecular and elemental differences in aqueous humor and ocular tissues in patients with primary open-angle glaucoma (POAG) and cataract compared with cataract controls without glaucoma. Samples of aqueous humor (~100 µL) will be collected intraoperatively from the anterior chamber, and ocular tissues routinely removed during surgery (anterior lens capsule and, in the glaucoma group, scleral tissue) will be obtained for laboratory analyses.
Participants will undergo standard clinical assessment including intraocular pressure (IOP), optic nerve head evaluation, optical coherence tomography (OCT) with retinal nerve fiber layer (RNFL) analysis, and automated perimetry (Humphrey SITA Standard 24-2). Elemental profiling will be performed using ICP-MS (with LA-ICP-MS mapping in selected samples), and proteomic profiling will be conducted using LC-MS/MS with bioinformatic analysis.
The aim is to identify glaucoma-associated chemical and proteomic patterns that may serve as potential diagnostic or prognostic biomarkers and improve understanding of glaucoma pathophysiology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Scheduled for cataract surgery (phacoemulsification with intraocular lens implantation).
- •Ability to provide written informed consent.
- •For glaucoma arm: diagnosis of primary open-angle glaucoma (POAG) with coexisting cataract, and planned combined cataract surgery with glaucoma procedure.
- •For control arm: cataract without glaucoma and without other significant ocular pathology.
排除标准
- •Age < 18 years.
- •Pregnancy or breastfeeding.
- •Advanced visual impairment in the study eye (visual aquity worse than counting fingers).
- •Any glaucoma type other than primary open-angle glaucoma (e.g., angle-closure, secondary, neovascular glaucoma).
- •History of intraocular surgery in the study eye (including glaucoma surgery), vitreoretinal surgery, corneal transplantation, or refractive surgery.
- •Active or previous uveitis.
- •Other significant chronic ocular disease in the study eye (other than cataract and POAG in the glaucoma arm).
- •Inability to comply with study procedures or follow-up visits.
研究组 & 干预措施
Glaucoma + Cataract Group
干预措施: Phacoemulsification With Intraocular Lens Implantation and Deep Sclerectomy (Procedure)
Cataract Control Group
干预措施: Phacoemulsification With Intraocular Lens Implantation (Procedure)
结局指标
主要结局
IOP
时间窗: Through study completion, an average of 1 year
Intraocular Pressure
Visual Field
时间窗: Through study completion, an average of 1 year
Visual Field of the mean defect (MD)
BCVA
时间窗: Through study completion, an average of 1 year
Best-corrected visual acuity
Protein expression
时间窗: Through study completion, an average of 1 year
Measured by ICP-MS/LC-MS
RNFL
时间窗: Through study completion, an average of 1 year
Retinal Nerve Fiber Layer (OCT)
次要结局
- Medications(Through study completion, an average of 1 year)