Optic Nerve Compliance Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Optic Disc Change
研究概览
简要总结
Chronic glaucoma is one of the leading causes of blindness and visual loss in the developed world. It is a condition where long term exposure to high eye pressures (intra-ocular pressure) damages the nerve fibres in the eye. This damage can be seen by examiners as changes in the optic nerve. The exact mechanism of how the high intra-ocular pressure causes nerve damage is unknown. Both physiological and mechanical mechanisms are thought to play a role. Previous authors have reported structural changes in the connective tissue of optic nerves of eyes with glaucoma. Structural changes in the optic nerve head which affect the mechanical compliance of the nerve may be significant in the cause of glaucomatous nerve damage. This study aims to assess the compliance of the optic disc in subjects with and without glaucoma. We would test compliance by imaging the optic discs of participants before and during a brief (less than two minutes) increase in intra-ocular pressure. We would aim to repeat the tests on the same subjects 3 years later to see how compliance changed. We would also seek to correlate other important parameters such as corneal thickness and visual field changes with our findings
详细描述
Chronic glaucoma is one of the leading causes of blindness and visual loss in the developed world (the following reference gives rate of visual impairment/blindness caused by glaucoma in one cross-section of an older Australian population as 6% - Foran S, Wang JJ, Mitchell P. Causes of visual impairment in two older population cross-sections: the Blue Mountains Eye Study. Ophthalmic Epidemiol. 2003 Oct;10(4):215-25). Glaucoma is a condition where long term exposure to high eye pressures (intra-ocular pressure) damages the nerve fibres in the eye. The exact mechanism of how the high intra-ocular pressure causes nerve damage is unknown (Albon J, Purslow PP, Karwatowski WS, Easty DL. Age related compliance of the lamina cribrosa in human eyes. Br J Ophthalmol. 2000 Mar;84(3):318-23). Both physiological and mechanical mechanisms are thought to play a role. Previous authors have reported structural changes in the connective tissue of optic discs of eyes with glaucoma, and postulated that this may contribute to changes in the compliance of the optic nerve head (Pena JD, Netland PA, Vidal I, Dorr DA, Rasky A, Hernandez MR. Elastosis of the lamina cribrosa in glaucomatous optic neuropathy. Exp Eye Res. 1998 Nov;67(5):517-24). Structural changes in the optic nerve head which affect the mechanical compliance of the nerve may be significant in the cause of glaucomatous nerve damage. This study aims to assess the compliance of the optic disc in subjects with and without glaucoma. We would test compliance by imaging the optic discs of participants before and during a brief increase in intra-ocular pressure. We would aim to repeat the tests on the same subjects 3 years later to see how the optic nerve compliance changed. We would also look to correlate changes with other ocular parameters such as corneal thickness and visual field defects.
- Non-glaucoma group
Inclusion criteria:
Age over 18
Exclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Age over 18, Diagnosis of glaucoma (visual field proven), Stable, well controlled glaucoma
排除标准
- •Previous eye surgery, Best corrected visual acuity <6/9, Chronic eye disease (including glaucoma, Secondary glaucoma (eg uveitis, neovascular glaucoma, etc), Advanced or fixation-threatening visual field changes, Ocular perfusion abnormalities (e.g. previous retinal artery or vein occlusion; or abnormal vasculature including those whose retinal circulation might be compromised by pressure on the eye).
结局指标
主要结局
Optic Disc Change
Visual Field Progression
次要结局
- Visual Acuity Change