Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus

NYU Langone Health1 个研究点分布在 1 个国家目标入组 3 人开始时间: 2018年11月15日最近更新: 2025年1月29日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方: NYU Langone Health
入组人数: 3
试验地点: 1
主要终点: Number of Patients With Tissue Deformation in ONH Region

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The mechanism by which vision loss in glaucoma occurs is still unknown, but it is clear that increased Intraocular Pressure (IOP) is a major risk factor. It is also thought that the lamina cribrosa (LC) is a site of primary damage during the pathogenesis of the disease. The changes caused by intraocular pressure (IOP) modulation at the level of the optic nerve head and LC will be evaluated in the present study. Subjects with keratoconus exhibit abnormal collagen properties that can impair their LC behavior. By evaluating their lamina biomechanical response we can advance our understanding on the role of the lamina in glaucoma pathogenesis. A better understanding of the process will ultimately lead to improved detection and management of glaucoma.

It is hypothesized that subjects with keratoconus have an abnormal biomechanical response of the lamina cribrosa in response to IOP modulation.

研究设计

研究类型: Interventional
分配方式: Non 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 90 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Candidates must meet the following inclusion criteria in order to participate in the study.
•Ability to provide informed consent and to understand the study procedures
•Keratoconus:
•Clinical diagnosis of keratoconus
•Central thinning of the cornea
•Abnormal posterior ectasia.
•Glaucomatous ONH abnormality: rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.
•Two consecutive abnormal SITA standard perimetry tests with GHT outside normal limits.

排除标准

•Candidates that meet any of the exclusion criteria at baseline will be excluded from study participation.
•Media opacity (e.g. lens, vitreous, cornea).
•Strabismus, nystagmus or a condition that would prevent fixation.
•Diabetes with evidence of retinopathy.
•Previous intraocular surgery or ocular trauma (with the exception of laser procedures and subjects that have undergone uneventful cataract surgery more than 6 months from enrollment date).
•Neurological and non-glaucomatous causes for visual field damage.
•Any intraocular non-glaucomatous ocular disorders.

干预措施: Optical Coherence Tomography (OCT) (Device)

结局指标

主要结局

Number of Patients With Tissue Deformation in ONH Region

时间窗: 1 Day

Determination of tissue deformation will be obtained from OCT images.

Change in Cup Depth (ONH Region) Under Elevated Intraocular Pressure

时间窗: 1 Day