Primary Open-angle GlaucomaMISONCT03098316
Metabolomics in Surgical Ophthalmological Patients
An observational study of Primary Open-angle Glaucoma and Low Tension Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Metabolomics consists in the study of metabolites in body fluids or tissues. It investigates the consequences of the activity of genes and proteins. One of its advantages is that it is able to do a simultaneous measurement of metabolic changes in living organisms as a response to a disturbance (disease, diet… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Primary Open-angle Glaucoma, Low Tension Glaucoma
- What is being tested?
- Metabolomics analysis of patient samples
- How many people
- 90 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Jan 2017to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients from the ophthalmology department that are undergoing intraocular surgery.
Who may be able to join
- glaucoma patients (POAG/NTG): undergoing trabeculectomy, XEN® implantation or cataract surgery
- Controls (non glaucoma): undergoing cataract surgery
- Caucasian
Who cannot join
- Diabetes mellitus
- any intra ocular surgery on study eye, other than clear cornea cataract surgery more than one year before
- other eye pathologies than the one the surgery is intended for (except refractive error and cataract in glaucoma patients), namely retinopathies, uveitis and other causes for neuropathy.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, Leuven, 3000
Sien Boons, 003216340391
Ingeborg Stalmans, MD, PhD
About this study
Metabolomics consists in the study of metabolites in body fluids or tissues. It investigates the consequences of the activity of genes and proteins. One of its advantages is that it is able to do a simultaneous measurement of metabolic changes in living organisms as a response to a disturbance (disease, diet, environment, others) and because a metabolic profile is summative of all the biochemical processes occurring in the body at a given time, it makes no presumption about the relative importance of these processes. Ultimately it is a fingerprint of the organism's health status, at a given time.
Metabolomic analysis of serum, plasma and urine has revealed panels of metabolites that distinguish patients with cardiovascular disease, breast cancer, Parkinson disease, Alzheimer's disease and diabetes from control patients. Regarding ocular diseases only few studies have been published, related to diabetic retinopathy, retinal detachment, age-related macular degeneration, uveitis and glaucoma.
Read more
Glaucoma is one of the leading causes of blindness in the world, according to the World Health Organization, and there are still no biomarkers that can provide an early diagnosis. Nowadays, glaucoma classification relies substantially in the measurement of intraocular pressure (IOP), which can be rather artificial and also unreliable since IOP values can fluctuate during the day. Moreover, patients with normal IOP values can also develop glaucomatous neuropathy (normal-tension glaucoma, NTG) and progress even when IOP is decreased. Several studies have shown that NTG patients suffer from a systemic vascular dysregulation, with higher rates of systemic hypotension, Raynaud phenomenon and migraine. Hence, other mechanisms than an increased IOP are of importance in the development and progression of glaucoma.
Only one metabolome-wide study has been made in glaucoma (Burgess, I.; 2015). In a sample of 72 american patients with primary open angle glaucoma (POAG), the authors found significant differences in comparison to controls.
The hypothesis for this study is that glaucoma patients will differ from controls, and POAG patients will differ from NTG patients. The investigators will look into metabolomics as a way to create a method to diagnose and stratify patients, as an add-on or alternative to the currently available diagnostic tools like IOP, functional and structural measurement.
Read the detailed description
This is a cross sectional study built to compare samples from glaucoma patients undergoing surgery (open-angle glaucoma and normal-tension glaucoma, age and gender matched) with age and gender-matched controls (healthy patients undergoing cataract surgery). For this the investigators will collect plasma, urine and aqueous humor to be analyzed through mass spectrometry and nuclear magnetic resonance spectroscopy. Patients have a night fasting period prior to sample collection, and a lifestyle and food frequency questionnaire is filled to control for nutritional influence on metabolites. Diabetic patients are excluded, since it would confound our analysis.
- Conditions
- Primary Open-angle Glaucoma, Low Tension Glaucoma
- Being tested
- Metabolomics analysis of patient samples
- Keywords
- Cross sectional studies, Metabolomics, Glaucoma, Low tension glaucoma, Ophthalmologic surgical procedures
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metabolomics analysis of patient samplesDiagnostic test
Metabolomics analysis of patient samples by mass spectrometry and nuclear magnetic resonance spectroscopy.
| Study group | Role | What they receive |
|---|---|---|
| POAG | Primary open angle glaucoma patients Receives: Diagnostic Test: Metabolomics analysis of patient samples | |
| NTG | Normal/Low tension glaucoma patients Receives: Diagnostic Test: Metabolomics analysis of patient samples | |
| Control | Patients with cataract and without glaucoma or other eye diseases Receives: Diagnostic Test: Metabolomics analysis of patient samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomics profile of each group
un-targeted metabolomics and identification of metabolites based on exact mass using metabolomics library
Measured: Morning of the surgery
Secondary outcomes (1)
Surgical success of glaucoma patients
Success is defined as an IOP between 6 and 18 mmHg with a reduction of 30% from baseline, and was sub-categorized as complete success if accomplished without glaucoma medication, qualified success with glaucoma medication, and total success as a combination of both complete and qualified. Eyes needing further glaucoma surgery, IOP ≤5 or > 18 mmHg on two consecutive visits, or loss of light perception due to glaucoma were considered as failures. Needling of encysted blebs is not considered a failure.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start31 Jan 2017
- Primary completion30 Sep 2017 (estimated)
- Study completion30 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Open-angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- FRO (Funds for Research in Ophthalmology, Belgium)
- Responsible party
- Principal investigator, Prof. Dr. Stalmans Ingeborg, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Ingeborg Stalmans, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098316
- Sponsor's protocol ID
- MISO Study
- Acronym
- MISO
- Status last verified
- Mar 2017
- First submitted
- 26 Mar 2017
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolomics in Surgical Ophthalmological Patients
- ClinicalTrials.gov ID
- NCT03098316
- Acronym / sponsor ID
- MISO / MISO Study
- Conditions
- Primary Open-angle Glaucoma, Low Tension Glaucoma
- Keywords
- Cross sectional studies, Metabolomics, Glaucoma, Low tension glaucoma, Ophthalmologic surgical procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- FRO (Funds for Research in Ophthalmology, Belgium)
- Study start
- 31 Jan 2017 (actual)
- Primary completion
- 30 Sep 2017 (estimated)
- Study completion
- 30 Sep 2018 (estimated)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Metabolomics consists in the study of metabolites in body fluids or tissues. It investigates the consequences of the activity of genes and proteins. One of its advantages is that it is able to do a simultaneous measurement of metabolic changes in living organisms as a response to a disturbance (disease, diet, environment, others) and because a metabolic profile is summative of all the biochemical processes occurring in the body at a given time, it makes no presumption about the relative importance of these processes. Ultimately it is a fingerprint of the organism's health status, at a given time.
Metabolomic analysis of serum, plasma and urine has revealed panels of metabolites that distinguish patients with cardiovascular disease, breast cancer, Parkinson disease, Alzheimer's disease and diabetes from control patients. Regarding ocular diseases only few studies have been published, related to diabetic retinopathy, retinal detachment, age-related macular degeneration, uveitis and glaucoma.
Glaucoma is one of the leading causes of blindness in the world, according to the World Health Organization, and there are still no biomarkers that can provide an early diagnosis. Nowadays, glaucoma classification relies substantially in the measurement of intraocular pressure (IOP), which can be rather artificial and also unreliable since IOP values can fluctuate during the day. Moreover, patients with normal IOP values can also develop glaucomatous neuropathy (normal-tension glaucoma, NTG) and progress even when IOP is decreased. Several studies have shown that NTG patients suffer from a systemic vascular dysregulation, with higher rates of systemic hypotension, Raynaud phenomenon and migraine. Hence, other mechanisms than an increased IOP are of importance in the development and progression of glaucoma.
Only one metabolome-wide study has been made in glaucoma (Burgess, I.; 2015). In a sample of 72 american patients with primary open angle glaucoma (POAG), the authors found significant differences in comparison to controls.
The hypothesis for this study is that glaucoma patients will differ from controls, and POAG patients will differ from NTG patients. The investigators will look into metabolomics as a way to create a method to diagnose and stratify patients, as an add-on or alternative to the currently available diagnostic tools like IOP, functional and structural measurement.
Detailed description
This is a cross sectional study built to compare samples from glaucoma patients undergoing surgery (open-angle glaucoma and normal-tension glaucoma, age and gender matched) with age and gender-matched controls (healthy patients undergoing cataract surgery). For this the investigators will collect plasma, urine and aqueous humor to be analyzed through mass spectrometry and nuclear magnetic resonance spectroscopy. Patients have a night fasting period prior to sample collection, and a lifestyle and food frequency questionnaire is filled to control for nutritional influence on metabolites. Diabetic patients are excluded, since it would confound our analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| POAG | – | Diagnostic Test: Metabolomics analysis of patient samplesPrimary open angle glaucoma patients |
| NTG | – | Diagnostic Test: Metabolomics analysis of patient samplesNormal/Low tension glaucoma patients |
| Control | – | Diagnostic Test: Metabolomics analysis of patient samplesPatients with cataract and without glaucoma or other eye diseases |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients from the ophthalmology department that are undergoing intraocular surgery.
Key inclusion criteria (3 listed)
- glaucoma patients (POAG/NTG): undergoing trabeculectomy, XEN® implantation or cataract surgery
- Controls (non glaucoma): undergoing cataract surgery
- Caucasian
Key exclusion criteria (3 listed)
- Diabetes mellitus
- any intra ocular surgery on study eye, other than clear cornea cataract surgery more than one year before
- other eye pathologies than the one the surgery is intended for (except refractive error and cataract in glaucoma patients), namely retinopathies, uveitis and other causes for neuropathy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metabolomics analysis of patient samplesMetabolomics analysis of patient samples by mass spectrometry and nuclear magnetic resonance spectroscopy. | Diagnostic test | Control, NTG, POAG |
Primary outcome
Metabolomics profile of each group
Time frame: Morning of the surgery
un-targeted metabolomics and identification of metabolites based on exact mass using metabolomics library
1 secondary outcome
Surgical success of glaucoma patients
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingeborg Stalmans, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Open-angle Glaucoma and Low Tension Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sien Boons (003216340391, sien.boons@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolomics profile of each group (time frame: Morning of the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.