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临床试验/NCT02547740
NCT02547740已完成不适用

Structural and Functional Progression of Glaucomatous Damage to the Macula

Columbia University1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
1
主要终点
Change in 10-2 visual field

研究概览

简要总结

Glaucoma is the leading cause of irreversible blindness worldwide. This study aims to test a new method that may allow earlier diagnosis of glaucoma and better ways to monitor if it is getting worse. There is scientific evidence that the macula, the central part of the retina, can be involved in very early stages of glaucoma. Glaucomatous damage to the macula is very prevalent and is often missed using conventional clinical tests.

Relatively little is known about progression of early glaucoma damage and its effects on the macula. This project investigates the nature of progressive damage to the macula and proposes new methods to improve accuracy to detect clinically significant progression.The study will evaluate the nature of damage to the macula's structures through OCT imaging and eye function via visual field tests.

详细描述

There is compelling evidence that glaucomatous damage to the macula occurs even in early stages of the disease. The macula comprises about 30% of all retinal ganglion cells and its information corresponds to over 50% of the visual cortex. However, glaucomatous damage to the macula is often missed in clinical practice. Some of the reasons are:

  1. traditional glaucoma knowledge supports that glaucoma is fundamentally a peripheral disease;
  2. inherent limitations of conventional clinical tests to detect damage to the macula; and
  3. the paucity of large, prospective studies that describe the nature of glaucomatous damage to the macula.

The investigators have published numerous papers in the past two years showing that macular damage is prevalent among patients with early glaucoma if one employs the appropriate tools to assess it, namely 10-2 visual fields and high-resolution optical coherence tomography (OCT). This information comes from a unique prospective cross- sectional database and techniques the investigators developed to produce objective metrics of structure and function.

Now that the investigators understand the cross-sectional nature of macular damage, this proposal aims to:

  1. develop a longitudinal database including patients with early glaucoma and healthy controls,
  2. to test models that explain progression of macular damage, and
  3. to apply new statistical methods combining structural and functional tests which could improve the accuracy to detect progression and shorten the length of clinical trials.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • glaucomatous optic neuropathy (as defined in the American Academy of Ophthalmology Preferred Practice Pattern criteria)

排除标准

  • late functional glaucomatous damage
  • significant cataract
  • previous ocular surgery (aside from uncomplicated cataract extraction with intraocular lens (IOL) implantation and/or trabeculectomy, LASIK or refractive surgeries)
  • diabetic retinopathy with macular edema
  • vein or artery occlusion
  • exudative age-related macular degeneration or geographic atrophy
  • macular hole or traction
  • amblyopia
  • non-open angle glaucoma (e.g. angle closure, traumatic, congenital glaucoma)
  • severe myopia or hyperopia (refractive error greater than -6 or +6D, respectively)
  • retinal detachment (current or post-surgery)
  • retinitis pigmentosa
  • significant epiretinal memberane
  • significant kerotoconus
  • Healthy Group:
  • Inclusion Criteria:
  • best corrected visual acuity equal or better than 20/40
  • normal biomicroscopy examination
  • gonioscopically open angles
  • Intraocular Pressure (IOP) lower than 22 mmHg
  • normal and reliable 24-2 and 10-2 SAP results
  • Exclusion Criteria:
  • evidence of optic neuropathy
  • evidence of clinically significant metabolic diseases (e.g. diabetes and hypotension)

结局指标

主要结局

Change in 10-2 visual field

时间窗: Baseline and 3 years

Evidence of functional glaucomatous damage on the macula as confirmed by visual fields: A slope of 10-2 visual field change faster than -1 dB/year at P\<5%

Change in macular ganglion cell thickness

时间窗: Baseline and 3 years

Evidence of structural glaucomatous damage on the macula as confirmed by OCT imaging: evidence of macular ganglion cell thickness slope less than -10 microns/year

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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