Morphometric Markers of the Effectiveness of Micropulse Cyclophotocoagulation: The Influence of Choroidal Thickness on the Extent and Duration of the Hypotensive Effect
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
研究概览
简要总结
This prospective study aims to evaluate morphometric markers of treatment response following micropulse transscleral cyclophotocoagulation (MP-CPC) in patients with glaucoma. The study will assess changes in choroidal thickness and the choroidal vascularity index (CVI) measured by optical coherence tomography (OCT) before treatment, 3-7 days after the procedure, and 1 month postoperatively.
Intraocular pressure (IOP) will be measured at the same time points. The correlation between changes in choroidal thickness, the choroidal vascularity index (CVI) and IOP reduction will be analyzed. Additionally, the study seeks to determine the minimal baseline choroidal thickness associated with a clinically significant hypotensive effect after MP-CPC.
详细描述
Glaucoma is a chronic progressive optic neuropathy characterized by irreversible visual field loss. Reduction of intraocular pressure (IOP) remains the only evidence-based strategy to slow disease progression. Micropulse transscleral cyclophotocoagulation (MP-CPC) has become an increasingly used laser modality due to its favorable safety profile compared to continuous-wave cyclophotocoagulation.
Despite demonstrated efficacy, the magnitude and durability of the hypotensive effect after MP-CPC vary considerably among patients. Identification of structural ocular biomarkers associated with treatment response may improve patient selection and enable a more individualized therapeutic approach.
The choroid plays a key role in ocular blood flow regulation and may influence aqueous humor dynamics, particularly uveoscleral outflow. Variations in choroidal thickness may reflect differences in vascular reactivity, tissue compliance, and structural characteristics that could modulate the biological response to laser energy.
This prospective study will include patients with various types of glaucoma scheduled to undergo MP-CPC. Subfoveal choroidal thickness and the choroidal vascularity index (CVI) will be measured using enhanced depth imaging optical coherence tomography (EDI-OCT) at three time points: Preoperatively (baseline), 3-7 days after MP-CPC, 1 month after MP-CPC Intraocular pressure will be assessed at the same time points using Corvis ST tonometry.
The primary objective of the study is to evaluate the correlation between changes in choroidal thickness, the choroidal vascularity index (CVI) and IOP reduction at early (3-7 days) and short-term (1 month) follow-up.
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
- 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
- •Decision to treat by MP-CPC Laser
- •Patients diagnosed with Glaucoma
- •Patients aged 18 years old and above
- •Glaucoma that is inadequately controlled on medical therapy
排除标准
- •Patients age less than 18 years
- •Patients unable or unwilling to provide informed consent to participate in the study
- •Patients potentially unavailable for follow up visits
- •Patients with significant scleral thinning
- •Patients with ocular infection, inflammation or intraocular surgery in the study eye 2 months prior to enrollment in the study
- •Albino patients that have no iris pigmentation
研究组 & 干预措施
MicroPulse transscleral cyclophotocoagulation group
Participants in this group will undergo MicroPulse transscleral cyclophotocoagulation for glaucoma. The procedure will be performed using a laser power of 2500 mW, with a treatment duration of 100-120 seconds per hemifield and 5-6 sweeps per hemifield.
干预措施: MicroPulse transscleral cyclophotocoagulation (Procedure)
Conventional transscleral cyclophotocoagulation group
Participants in this group will undergo conventional transscleral cyclophotocoagulation for glaucoma. The procedure will be performed using a laser power of 1.4-2.3 W, with an exposure duration of 1.4-1.8 seconds per coagulation spot.
干预措施: Conventional transscleral cyclophotocoagulation (Procedure)
