Olfactory Function in Glaucoma Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
研究概览
简要总结
Glaucoma is one of the leading causes of blindness worldwide. The key feature of glaucoma is damage to the optic nerve head with loss of retinal ganglion cells and local tissue remodeling. Neuronal cell death in glaucoma occurs by apoptotic mechanisms1. Apoptosis of neurons also plays a major role in neurodegenerative diseases, such as Alzheimer's or Parkinson's disease. An association between glaucoma and these disorders has been described 2-4. Furthermore, it has been reported that the olfactory function is disturbed in these neurodegenerative diseases5-6. We hypothesize that similar olfactory alterations may occur in glaucoma which is in fact a local neurodegenerative disease.
详细描述
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Introduction
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Background and rationale of the study Glaucoma is one of the leading causes of blindness worldwide. The key feature of glaucoma is damage to the optic nerve head with loss of retinal ganglion cells and local tissue remodeling. Neuronal cell death in glaucoma occurs by apoptotic mechanisms1. Apoptosis of neurons also plays a major role in neurodegenerative diseases, such as Alzheimer's or Parkinson's disease. An association between glaucoma and these disorders has been described 2-4. Furthermore, it has been reported that the olfactory function is disturbed in these neurodegenerative diseases5-6. We hypothesize that similar olfactory alterations may occur in glaucoma which is in fact a local neurodegenerative disease.
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Study objectives Primary Objective: To test the olfactory function in glaucoma patients.
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Investigational plan Chronic glaucoma patients will be assessed regarding inclusion/exclusion criteria and clinical criteria. A basic otorhinolaryngological examination addressing the possible exclusion criteria will be performed prior to the Sniffing Sticks test battery. A simple questionnaire regarding an olfactory status of the patient will be filled out. The olfactory performance of glaucoma patients will be compared to the existing age-matched normative database.
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Design Single center cohort study, normative database as control.
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Selection of study population
I. Number of subjects Thirty consecutive glaucoma patients, age 18 - 70, will be recruited from the glaucoma consultation at the University Eye Clinic Basel.
II. Prestudy screening A detailed medical and ophthalmic history will be recorded and all patients will complete an ophthalmologic examination (best corrected visual acuity, intraocular pressure measurements, slit-lamp examination, indirect fundoscopy) as well as an otorhinolaryngological examination.
III. Inclusion criteria Diagnosis of chronic open-angle glaucoma will be based on the presence of typical glaucomatous disc damage and visual field defects. Only patients with a recent gonioscopic examination and at least two visual field examinations will be recruited.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 17 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic open-angle glaucoma with typical glaucomatous disc and visual field damage.
排除标准
- •Occludable iridocorneal angles
- •History of current, chronic or recurrent inflammatory eye disease
- •History of retinal or neuroophthalmologic disease that could result in visual field defects
- •Need for any concomitant medications that may interfere with the evaluation of olfactory function
- •Patients with a significant history and/or active alcohol or drug abuse (significant is defined as that which in the opinion of the investigator may either put the patient at risk because of participation in the study or may influence the results of the study or the patient's ability to participate in the study), smokers
- •History of olfactory disturbance related to identifiable local factors and any local condition that could lead to hyposmia/anosmia or interfere with the olfactory function, such as polyps, chronic sinus infection, sub(acute) viral or bacterial infection, history of sinus surgery