Development of Robust Corneal Biomechanical Biomarkers for Glaucoma Using Brillouin Microscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Corneal Biomechanical Modulus
研究概览
简要总结
This pilot study evaluates the biomechanical properties of the cornea in glaucoma patients using Brillouin microscopy, a non-contact imaging technique. The study aims to compare corneal stiffness between patients with normal-tension glaucoma, high-tension glaucoma, and healthy controls, and to assess changes in corneal biomechanics following intraocular pressure (IOP)-lowering treatment. The goal is to determine whether Brillouin-derived biomechanical measurements can serve as biomarkers for glaucoma risk and progression.
详细描述
This study explores the biomechanical properties of the cornea in patients with glaucoma using a novel, non-contact imaging technique called Brillouin microscopy. The technology allows in vivo assessment of tissue stiffness without physical perturbation, potentially offering new insights into glaucoma risk and response to therapy.
The study includes two parts: a cross-sectional comparison between patients with normal- and high-tension glaucoma and healthy controls, and a longitudinal analysis of biomechanical changes following IOP-lowering treatment with either prostaglandin analogs or beta blockers.
The goal is to determine whether corneal biomechanics can serve as a biomarker for glaucoma susceptibility and progression, and to evaluate the feasibility of integrating Brillouin imaging into clinical glaucoma care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Age 18 years or older
- •Diagnosis of primary open angle glaucoma (POAG) or no history of glaucoma (for controls)
- •Open angle on gonioscopy (Shaffer grade 3 or 4)
- •Best-corrected visual acuity of 20/25 or better
- •Refractive error between +3.00 and -5.00 diopters
- •No prior use of topical glaucoma medications
- •Diagnosis of:
- •High Tension Glaucoma (IOP ≥ 22 mmHg on 3 visits)
- •Normal Tension Glaucoma (IOP ≤ 21 mmHg on 3 visits)
- •OR age-matched control with normal optic nerve and visual fields
排除标准
- •Corneal abnormalities or conditions interfering with Brillouin or applanation tonometry
- •Retinal diseases affecting RNFL (e.g., macular traction)
- •History of ocular surgery or laser
- •Diagnosis of diabetes
- •History of uveitis
- •History of prolonged steroid use
- •Neurodegenerative or systemic diseases (e.g., multiple sclerosis, Alzheimer's, Parkinson's, schizophrenia)
- •Unreliable visual fields
- •Contraindications to beta blockers (e.g., bradycardia, severe pulmonary disease)
- •Moderate to severe glaucoma (per Hodapp-Anderson-Parrish criteria)
- •History of contact lens use
- •Low blood pressure
研究组 & 干预措施
Normal Tension Glaucoma
Newly diagnosed, treatment-naïve subjects with normal tension glaucoma. Brillouin imaging will be performed at baseline, and in a subset receiving IOP-lowering therapy, additional imaging will be performed at 3 and 6 weeks.
干预措施: Brillouin Microscopy (Device)
High Tension Glaucoma
Newly diagnosed, treatment-naïve subjects with high tension glaucoma. Brillouin imaging will be performed at baseline, and in a subset receiving IOP-lowering therapy, additional imaging will be performed at 3 and 6 weeks.
干预措施: Prostaglandin Analogue -Containing IOP-Lowering Therapy (Drug)
High Tension Glaucoma
Newly diagnosed, treatment-naïve subjects with high tension glaucoma. Brillouin imaging will be performed at baseline, and in a subset receiving IOP-lowering therapy, additional imaging will be performed at 3 and 6 weeks.
干预措施: Brillouin Microscopy (Device)
Control
Age-matched healthy control subjects with no history of glaucoma or IOP-lowering therapy. Brillouin imaging will be performed at a single time point for cross-sectional comparison.
干预措施: Brillouin Microscopy (Device)
High Tension Glaucoma
Newly diagnosed, treatment-naïve subjects with high tension glaucoma. Brillouin imaging will be performed at baseline, and in a subset receiving IOP-lowering therapy, additional imaging will be performed at 3 and 6 weeks.
干预措施: Beta Blocker (Drug)
Normal Tension Glaucoma
Newly diagnosed, treatment-naïve subjects with normal tension glaucoma. Brillouin imaging will be performed at baseline, and in a subset receiving IOP-lowering therapy, additional imaging will be performed at 3 and 6 weeks.
干预措施: Beta Blocker (Drug)
Normal Tension Glaucoma
Newly diagnosed, treatment-naïve subjects with normal tension glaucoma. Brillouin imaging will be performed at baseline, and in a subset receiving IOP-lowering therapy, additional imaging will be performed at 3 and 6 weeks.
干预措施: Prostaglandin Analogue -Containing IOP-Lowering Therapy (Drug)
结局指标
主要结局
Change in Corneal Biomechanical Modulus
时间窗: Baseline, 3 weeks, and 6 weeks
Brillouin microscopy will be used to measure the corneal modulus of elasticity. The primary outcome is the change in corneal stiffness (Brillouin shift in MHz) across time points in subjects treated with prostaglandin analogs versus beta blockers, and between groups at baseline (NTG, HTG, controls).
次要结局
未报告次要终点