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临床试验/NCT04610008
NCT04610008已完成不适用

Optic Nerve Head Shape as a Predictor of the Formation of Acquired Pits of the Optic Nerve (APONs)

Cardiff and Vale University Health Board1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2020年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Optic disc radius ratio

研究概览

简要总结

Acquired pits of the optic nerve (APONs) are an area of focal loss of neural tissue associated with a discrete area of depression/excavation within the optic cup at the level of the lamina cribrosa. It is commonly associated with glaucoma and can be seen on the optic disc when examining the back of a patient's eye. It causes a characteristic visual field defect in the central 5-10 degrees of vision which has a significant impact of a patient's daily activities. There is no treatment to restore vision once it has formed.

Previous studies suggest mechanical stress across this part of the eye may have role in the formation of APONs. The investigators therefore hypothesise that if a patient has a more elliptical shaped optic disc, which would have more irregular mechanical stress across it, it may have a higher risk of an APON forming.

Patients with glaucoma attending the ophthalmology department at University Hospital of Wales have regular photographs taken of the optic nerve/optic disc as part of their routine clinical care in order to monitor the condition. The research team, who are all practicing ophthalmologists in the department, will review anonymised photographs to find optic discs with APONs, and another group with glaucoma but no APONs to use as a control. The research team will then measure the dimensions of the optic disc to determine if APONs are more common in optic discs with a more elliptical shape. The patients' clinical notes will then need to be accessed to collect data on the age, sex and diagnosis. This data will be anonymised using ID numbers once collected.

The final outcomes of the study will the average measured dimensions of the optic disc in each group, and the position that the APON occurs.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 110 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Documented diagnosis of primary open angle glaucoma (POAG) or normal tension glaucoma (NTG)
  • Under the care of the ophthalmology department at University Hospital of Wales
  • Available optic disc photograph
  • Presence of an APON for disease group, no APON for control group

排除标准

  • No documented diagnosis of POAG/NTG
  • Other form of glaucoma - e.g. traumatic glaucoma/juvenile glaucoma
  • Poor photograph quality
  • Optic disc tilted so that the margin is obscured and cannot be demarcated
  • Coexisting disc pathology, e.g. congenital optic disc pit

结局指标

主要结局

Optic disc radius ratio

时间窗: 6 months

Comparison of the ratio of the maximum/minimum optic disc radius for optic discs with APONs and optic discs with glaucoma but no APON.

次要结局

  • The percentile rank of the disc radius at the position of the APON(6 months)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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