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临床试验/NCT05352854
NCT05352854Unknown不适用

In Vivo Morphological Changes of Ciliary Body and Trabecular Meshwork in High Myopia Eyes With Open-angle Glaucoma in Their Accommodation Induced by Pilocarpine

Yune Zhao0 个研究点目标入组 120 人开始时间: 2022年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
120
主要终点
Morphology of ciliary body

研究概览

简要总结

Glaucoma is the leading cause of irreversible blindness worldwide. Although the pathogenesis remains unclear, pathologic increase in intraocular pressure (IOP) due to blocked aqueous outflow through the trabecular-Schlemm canal is known to be an important risk factor, and reduction of IOP is the only clinically validated way to retard the progression of OAG. Ciliary muscle plays a central role in the trabecular meshwork-Schlemm canal outflow pathway. Clinical evidence suggests that ciliary muscle contraction stimulated by cholinergic receptor agonist and retraction of ciliary body position after cataract surgery can dilate the lumen of Schlemm canal and reduce IOP. Currently, Ultrasound biomicroscopy (UBM) can obtain two-dimensional images of the anterior segment using high-frequency Ultrasound transducers in medical imaging studies of the ciliary body - trabecular meshwork -Schlemm canal complex. UBM has better tissue penetration than Optical coherence tomography (OCT) and can image the ciliary body better, but it has a lower resolution (30um to 50um) and is poor at imaging tiny tissues such as trabecular meshwork and Schlemm canal. The latest swept-source OCT (SS-OCT) has faster image capture rate (1000000 A scans/SEC), stronger penetration and higher resolution (8um axial resolution and 20um transverse resolution). The structure and morphology of ciliary body-trabecular meshwork-Schlemm canal complex can be clearly photographed. The investigators intend to use CASIA2 to image the ciliary body-trabecular meshwork-Schlemm canal complex before and after administration of pilocarpine in healthy individuals and patients with glaucoma to assess the effect of pilocarpine on the anatomy of the ciliary body-trabecular meshwork-Schlemm canal complex.

详细描述

Glaucoma is the leading cause of irreversible blindness worldwide. Although the pathogenesis remains unclear, pathologic increase in intraocular pressure (IOP) due to blocked aqueous outflow through the trabecular-Schlemm canal is known to be an important risk factor, and reduction of IOP is the only clinically validated way to retard the progression of OAG. Ciliary muscle plays a central role in the trabecular meshwork-Schlemm canal outflow pathway. When the ciliary muscle contraction, the elastic fiber network will pull trabecular meshwork away from Schlemm canal direction, trabecular meshwork and adjacent tissue gap increases, increasing aqueous outflow. Clinical evidence suggests that ciliary muscle contraction stimulated by cholinergic receptor agonist and retraction of ciliary body position after cataract surgery can dilate the lumen of Schlemm canal and reduce IOP. Currently, Ultrasound biomicroscopy (UBM) can obtain two-dimensional images of the anterior segment using high-frequency Ultrasound transducers in medical imaging studies of the ciliary body - trabecular meshwork -Schlemm canal complex. UBM has better tissue penetration than Optical coherence tomography (OCT) and can image the ciliary body better, but it has a lower resolution (30um to 50um) and is poor at imaging tiny tissues such as trabecular meshwork and Schlemm canal. The latest swept-source OCT (SS-OCT) has faster image capture rate (1000000 A scans/SEC), stronger penetration and higher resolution (8um axial resolution and 20um transverse resolution). The structure and morphology of ciliary body-trabecular meshwork-Schlemm canal complex can be clearly photographed. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can accurately image the ciliary body-trabecular meshwork-Schlemm canal complex. The investigators intend to use CASIA2 to image the ciliary body-trabecular meshwork-Schlemm canal complex before and after administration of pilocarpine in healthy individuals and patients with glaucoma to assess the effect of pilocarpine on the anatomy of the ciliary body-trabecular meshwork-Schlemm canal complex.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Emmetropia/low myopia,high myopia, primary open-angle glaucoma without high myopia, and high myopia with primary open-angle glaucoma
  • have a good gaze to complete the test required inspection;

排除标准

  • hypersensitivity to pilocarpine
  • History of eye surgery, including cataract surgery, anti-glaucoma surgery, corneal surgery, retinal surgery, and eye trauma
  • history of systemic diseases that may affect the eyes (such as diabetes, hypertension, etc.)
  • intraocular chronic inflammatory diseases (uveitis, etc.), retinal diseases (retinal detachment, diabetic retinopathy, retinitis pigmentosa, etc.)
  • Corneal scars and severe cataracts affect OCT imaging
  • Eye diseases (angle-closure glaucoma, abnormal anterior segment development, neovascularization, etc.) that can affect trabecular meshwork and Schlemm canal structure.

研究组 & 干预措施

Health control

Experimental

emmetropia/low myopia (equivalent spherical lens > -3.00d, astigmatism ≤ 1.5d), best corrected visual acuity ≥1.0

干预措施: 0.5% pilocarpine eye drops (Drug)

High myopia

Experimental

Equivalent spherical lens ≤-6.00D or axial length ≥26.5mm

干预措施: 0.5% pilocarpine eye drops (Drug)

Primary open angle glaucoma

Experimental

emmetropia/low myopia (equivalent spherical lens > -3.00d, astigmatism ≤ 1.5d), diagnosed as POAG

干预措施: 0.5% pilocarpine eye drops (Drug)

HM-POAG

Experimental

Equivalent spherical lens ≤-6.00D or axial length ≥26.5mm,diagnosed as POAG

干预措施: 0.5% pilocarpine eye drops (Drug)

结局指标

主要结局

Morphology of ciliary body

时间窗: 40 minutes after the intervention(local application of pilocarpine eye drops)

measurement of Morphology of ciliary body using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software

Morphology of trabecular meshwork

时间窗: 40 minutes after the intervention(local application of pilocarpine eye drops)

measurement of Morphology of trabecular meshwork using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device) and Image J software

次要结局

未报告次要终点

研究者

发起方
Yune Zhao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Wenzhou Medical University

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