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临床试验/NCT00262626
NCT00262626终止不适用

A Multicentre Study on the Risk Factors for the Progression of Open-Angle Glaucoma

Dalhousie University4 个研究点 分布在 1 个国家目标入组 430 人开始时间: 1995年2月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
430
试验地点
4
主要终点
Visual field progression

研究概览

简要总结

Glaucoma is a disease which affects between one and two percent of all individuals aged over 40 years. According to recent Canadian National Institute for the Blind figures, it is the second largest specific cause of blindness in this country. The most common form of glaucoma, open-angle glaucoma, is incipient and typically results in a progressive loss of vision without symptoms due to damage to a structure inside the eye called the optic nerve head. Although the most important known risk factor for the development of open-angle glaucoma is high intraocular pressure (the pressure within the eyeball), a number of researchers have shown that a sizeable proportion of patients continue to lose vision in spite of successful treatment to lower their intraocular pressure. This finding suggests that there may be additional risk factors involved. Ocular vasospasm (the inability of certain blood vessels to dilate and increase blood flow according to the needs the eye) and vascular disease are among other factors implicated but their roles have not yet been fully investigated. The Canadian Glaucoma Study Group proposes to investigate the role of risk factors, including vasospasm and vascular disease, involved in the progression of open-angle glaucoma. We will recruit 410 patients with open-angle glaucoma across 4 centres (Halifax, Vancouver, Montreal and Toronto) who will be treated by experienced investigative ophthalmologists according to a uniform standard protocol to ensure that all patients are managed in the same manner. The patients will be followed meticulously with the most modern and accurate tests available every four months for a period of 5 years to determine whether progression has taken place. Visual function will be measured using two techniques called conventional perimetry and blue-on-yellow perimetry, and optic nerve heads will be examined with a special scanner capable of three-dimensional imaging. By defining both the ocular and systemic profiles of patients who progress and do not progress, we may be able to identify which patients will benefit from the standard treatment of intraocular pressure reduction, such as that prescribed in the study. More importantly, we will identify the characteristics of patients who do not benefit from standard treatment, so that alternative ones may be developed. Such studies are clearly necessary, but have not yet been conducted. We believe that the proposed study will increase our knowledge of open-angle glaucoma and reduce its impact on blindness and visual disability.

详细描述

Elevated intraocular pressure is the most important known risk factor for the development and progression of open-angle glaucoma. While pressure reduction is beneficial in many cases, a significant proportion of patients continue to progress despite clinically acceptable pressure levels. Many investigators have found no differences in pressure characteristics between progressing and non-progressing patients, highlighting our current inability to identify which patients will respond to pressure reduction. It is likely that this inability stems from our poor understanding of the risk factors, both ocular and systemic, for progression and the probability that glaucoma is a disease with multiple pathogenic mechanisms.

In this application the Canadian Glaucoma Study Group proposes a multi-centre prospective study with the objective of characterising the risk factors associated with the progression of open-angle glaucoma. We will determine sub-groups of patients with regard to the type of progression, thereby allowing us to identify the ocular and systemic profiles of patients who are likely to and not likely to benefit from intraocular pressure reduction.

Our hypotheses are:

(i) The relationship between intraocular pressure characteristics during follow-up and survival rates with regard to progression of open-angle glaucoma is weak.

(ii) Patients with vasospasm have a higher survival rate than patients without vasospasm with the clinical management prescribed in this study.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
0 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Best corrected visual acuity of at least 6/
  • •Previous visual field examinations showing nerve fibre bundle visual field defects characteristic of open-angle glaucoma and/or previous optic nerve head photographs showing cupping or notching characteristic of open-angle glaucoma.
  • •Total visual field damage [in the eligibility visual field (see Section 6.1)] of between 2 and 10 dB using the visual field index Mean Deviation.46
  • •Access to patient's previous ocular history and availability of initial untreated intraocular pressure (minimum of three readings).
  • •(d) Normal non-closable angles by gonioscopy. (e) Willingness to participate in the study and to give informed consent.

排除标准

  • •Non-glaucomatous ocular disease.
  • •Systemic disease known to affect the visual field or ability to participate in the study.
  • •Systemic beta-blockers.
  • •Chronic ocular medication other than for glaucoma.
  • •Previous incisional ocular surgery.
  • •(e) Distance refraction exceeding 6.00 diopters equivalent sphere or 2.50 diopters of astigmatism.
  • •(f) Aphakia or pseudophakia. (g) Contact lens wear.

结局指标

主要结局

Visual field progression

次要结局

  • Optic disc progression

研究者

申办方类型
Other

研究点 (4)

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The Canadian Glaucoma Study | 临床试验