Appreciation of the Possibility of Dosing Neopterin in Eye Liquids. Pilot Study of Neopterin Dosage in Eye Liquids.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Detection and dosage of neopterin in the eye
研究概览
简要总结
The purpose of the study is to determine whether neopterin can be dosed in the fluid of the eye's anterior chamber for patient with non-inflammatory and non-infectious ophthalmic pathology.
详细描述
The study will be explained to subjects who are about to undergo ophthalmologic surgery. They will sign an informed consent and be included in the study. Urine sample will be collected specifically for the study. Eye's anterior chamber fluid will also be collected during the surgery as it is the usual practice (the sample is used for the neopterin dosage instead of being thrown away).
These samples will be centrifuged, frozen in a -80° C freezer. At the end of the study, all the samples will be sent to the central Lab for the neopterin dosage analysis. Results will be communicated to the principal investigator afterward.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years-old
- •Non inflammatory or non infectious ophthalmic pathology requiring puncture of eye's anterior chamber fluid.
- •Minimum of 200 microliter sample
- •Immunocompetent subjects
- •Signed and dated informed consent
- •Samples management in accordance with the pre-analytical conditions specified in the protocol
- •Non-inclusion criteria:
- •Age < 18 years-old
- •Subjects treated with intraocular corticoids, antibiotics or anti-inflammatory, locally or in systemic injection, prior to inclusion.
排除标准
- •Subjects who exercised his right of withdrawal
- •Study suspended on principal investigator, sponsor or health authorities' demand.
- •Deceased subjects
结局指标
主要结局
Detection and dosage of neopterin in the eye
时间窗: 3 month
HCL will detect and dose the neopterin in the eye's anterior chamber fluid
次要结局
- Neopterin concentration comparison between study values and reference value.(3 month)
- False positives identification and elimination.(3 month)