Non-Arteritic Anterior Ischemic Optic Neuropathy Risk Factors: New Perspectives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 20
- 主要终点
- Anatomical characteristics on OCT
研究概览
简要总结
The purpose of the study is to use new diagnostic methods (OCT and OCT-A) to shed light on risk factors for the development of NA-AION. The risk factors we are focusing on are comorbidities along with anatomical and vascular characteristics of the optic nerve.
详细描述
Non-arteritic anterior ischemic optic neuropathy (NA-AION) is the most common acute optic neuropathy in the middle-aged and elderly population and can also occur in children and young adults. NA-AION leads to irreversible vision loss, and there is currently no effective treatment. In recent years, acellular calcified deposits in the optic nerve head called optic disc drusen (ODD) have been investigated as an important risk factor for NA-AION in patients under the age of 50.
The purpose of the study is to use new diagnostic methods optical coherence tomography (OCT) and OCT-angiography (OCTA) to shed light on risk factors for the development of NA-AION. We will perform two sub-studies:
- Characteristics of the optic nerve head anatomy including the presence of ODD as risk factors for the development of NA-AION.
- Vascular comorbidities and in vivo vasculature as a risk factor for developing NA-AION.
The study is an international prospective multicenter study including 20 sites in 9 different countries. The study population is patients diagnosed with NA-AION in a 1.5-year inclusion period. Each included patient gets 1-2 follow up visits during a 3-month follow up time.
Included patients will be examined as per standard clinical care for that site including OCT and OCT-A. Standard clinical care includes at least: obtaining medical history, measurement of visual acuity, slit lamp examination, and automated perimetry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of first episode of NA-AION in study eye with symptom onset within 1 month prior
- •Subject age: Age >10
- •NA-AION diagnosis requires:
- •disc edema seen by site PI or by referring doctor
- •visual field defect in the study eye consistent with NA-AION and mean deviation worse than 3.0 dB using the study visual field examination protocol
- •relative afferent pupillary defect (unless the fellow eye had previous NA-AION or other optic nerve or retinal disease that is not exclusionary)
排除标准
- •Previous episode of NA-AION in the study eye only
- •Intraocular pressure of >21 mm Hg in the study eye
- •Clinical or pathological evidence of giant cell arteritis
- •Diseases that may affect the optic nerve: glaucoma, multiple sclerosis, Alzheimer disease, and Parkinson disease. Evidence of optic disc drusen and optic nerve hypoplasia are not exclusion criteria given they are important parts of the study. We will not exclude significant retinal diseases, since they may be related to underlying etiologies giving rise to ODD, such as macular degeneration, retinal dystrophies, but eyes with significant retinal diseases will be analyzed separately.
结局指标
主要结局
Anatomical characteristics on OCT
时间窗: 3-months follow-up visit
Presence of ODD. Diameter of the scleral canal, disc area and rim on each quadrant of the optic disc, thickness of the peripapillary choroid, presence of peripapillary hyperreflective ovoid mass-like structures, and prelaminar hyperreflective lines.
Vascular characteristics on OCT-A
时间窗: 3-months follow-up visit
Transient versus persistent findings of ischemia, segmental location and extent of reduced vessel density. If ODD is present the vessel density will be compared to ODD location and volume.
次要结局
- Best corrected visual acuity(3-months follow-up visit)
- Visual field test(3-months follow-up visit)
- ODD characteristics(At 3-months follow-up visit)
- Questionnaire score: NEI-VFQ-25 including 10-item NO supplement score(3-months follow-up visit)
- Prevalence of comorbidities(At enrollment)
研究者
Steffen Hamann
MD, PhD, associate professor
Rigshospitalet, Denmark