Identifying Primary Open Angle Glaucoma Patients with Mitochondrial Dysfunctio
- Conditions
- glaucomaprimary open angle glaucoma10018307
- Registration Number
- NL-OMON53359
- Lead Sponsor
- Medisch Universitair Ziekenhuis Maastricht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 54
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
Limburg.
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
DNA
- 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.
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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Mitochondrial DNA copy number and mitochondrial function measured in in vitro<br /><br>assays of skin fibroblasts, compared between control (group 1) and POAG with<br /><br>low blood mtDNA copy number (group 2).<br /><br>Correlation between mitochondrial DNA copy number in the blood and<br /><br>mitochondrial function measured in fibroblasts within the POAG group (group 3). </p><br>
- Secondary Outcome Measures
Name Time Method