NL-OMON53359尚未招募不适用
Identifying Primary Open Angle Glaucoma Patients with Mitochondrial Dysfunction - Mitochondrial dysfunction in POAG patients
Medisch Universitair Ziekenhuis Maastricht0 个研究点目标入组 54 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 54
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •The source population is the population of the participants of the Eye Tissue
- •Bank Maastricht (ETBM). The ETBM is open for all glaucoma and cataract patients
- •of the University Eye Clinic Maastricht to participate. In general, this is an
- •elderly (glaucoma and cataract), Caucasian population inhabiting the south of
- •From the population of the ETBM, we previously selected the 175 participants of
- •the blood biomarker study: POAG patients and controls.
- •From these 175 participants of the blood biomarker study, we now select 3 study
- •groups for the current study.
- •4.2 Inclusion criteria
- •The blood biomarker study included 175 participants, POAG and Control from the
- •ETBM with the following criteria:
- •Inclusion criteria of the biomarker study:
- •- POAG group: Well-documented diagnosis of POAG.
- •- Control group: Well-documented ophthalmic history without glaucoma.
- •- Over 18 years old
- •Additional inclusion criteria of the current METC research proposal:
- •- Group 1: POAG patients with lowest values of mtDNA copy number in blood cell
- •- Group 2: POAG patients, randomly selected
- •- Group 3: Control patients, randomly selected; without glaucoma.
- •We aim to collect fibroblast cell lines from 15 individuals per group. We
- •expect to need skin biopsies from 15 to max 18 persons per group to achieve
- •this. We will try to select these from the participants of the previous blood
- •biomarker study. However, it will not be possible to include sufficient
- •participants (15 to max 18) from the control group of the blood biomarker study
- •to reach the required number of 15 individual fibroblast cell lines for the
- •control group of the current study. To complete the required number for this
- •group we will include additional control participants who we select directly
- •(and randomly) from the source population (Eye Tissue Bank Maastricht),
- •applying all appropriate inclusion and exclusion criteria of this control group
- •and applying the age range which is present in the other (POAG) study groups of
- •the current study.
排除标准
- •Exclusion criteria of the blood biomarker study:
- •- Systemic diseases in which mitochondria may be involved.
- •- Use of drugs that affect mitochondrial function.
- •Additional exclusion criteria of the current METC research proposal:
- •- No informed consent
- •- Use of oral anti-coagulants
- •- Significant concurrent disease e.g., cancer, diabetes, neurological disorders
- •(except for glaucomatous disorders), heart-related disorders, blood/platelet
- •disorders or other diseases affecting the liver, kidney (except kidney stones)
- •or the lungs (except bronchitis).
- •- inherited metabolic disorder will be used as exclusion criterium for group 1
- •and 3, and as variable for group 2
- •- Other concurrent eye diseases e.g., uveitis, age-related macular degeneration
- •or diabetic retinopathy.
- •- Ongoing participation in other clinical trials that contain an intervention.
- •- Any other factor that in the opinion of the investigator excludes the patient
- •from the study.
研究者
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