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Metabolomics in Surgical Ophthalmological Patients (MISO)

This study is currently recruiting participants.
Verified March 2017 by Prof. Dr. Stalmans Ingeborg, Universitaire Ziekenhuizen Leuven
Sponsor:
ClinicalTrials.gov Identifier:
NCT03098316
First Posted: March 31, 2017
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
FRO (Funds for Research in Ophthalmology, Belgium)
Information provided by (Responsible Party):
Prof. Dr. Stalmans Ingeborg, Universitaire Ziekenhuizen Leuven
  Purpose

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.


Condition Intervention
Primary Open-angle Glaucoma Low Tension Glaucoma Diagnostic Test: Metabolomics analysis of patient samples

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Metabolomics in Surgical Ophthalmological Patients

Resource links provided by NLM:


Further study details as provided by Prof. Dr. Stalmans Ingeborg, Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Surgical success of glaucoma patients [ Time Frame: 12 months ]
    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.


Biospecimen Retention:   Samples Without DNA
Blood plasma, urine, aqueous humor

Estimated Enrollment: 90
Actual Study Start Date: January 31, 2017
Estimated Study Completion Date: September 30, 2018
Estimated Primary Completion Date: September 30, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
POAG
Primary open angle glaucoma patients
Diagnostic Test: Metabolomics analysis of patient samples
Metabolomics analysis of patient samples by mass spectrometry and nuclear magnetic resonance spectroscopy.
NTG
Normal/Low tension glaucoma patients
Diagnostic Test: Metabolomics analysis of patient samples
Metabolomics analysis of patient samples by mass spectrometry and nuclear magnetic resonance spectroscopy.
Control
Patients with cataract and without glaucoma or other eye diseases
Diagnostic Test: Metabolomics analysis of patient samples
Metabolomics analysis of patient samples by mass spectrometry and nuclear magnetic resonance spectroscopy.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients from the ophthalmology department that are undergoing intraocular surgery.
Criteria

Inclusion Criteria:

  • glaucoma patients (POAG/NTG): undergoing trabeculectomy, XEN® implantation or cataract surgery
  • Controls (non glaucoma): undergoing cataract surgery
  • Caucasian

Exclusion Criteria:

  • 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098316


Contacts
Contact: Sien Boons 003216340391 sien.boons@uzleuven.be

Locations
Belgium
University Hospitals Leuven Recruiting
Leuven, Belgium, 3000
Contact: Sien Boons    003216340391      
Principal Investigator: Ingeborg Stalmans, MD, PhD         
Sub-Investigator: Evelien Vandewalle, MD, PhD         
Sub-Investigator: João Barbosa-Breda, MD         
Sub-Investigator: Karel Van Keer, MD         
Sub-Investigator: Uwe Himmelreich, PhD         
Sub-Investigator: Bart Ghesquière, PhD         
Sub-Investigator: Anca Croitor Sava, PhD         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
FRO (Funds for Research in Ophthalmology, Belgium)
Investigators
Principal Investigator: Ingeborg Stalmans, MD, PhD University Hospitals Leuven
  More Information

Responsible Party: Prof. Dr. Stalmans Ingeborg, Head of the glaucoma department, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03098316     History of Changes
Other Study ID Numbers: MISO Study
First Submitted: March 26, 2017
First Posted: March 31, 2017
Last Update Posted: April 4, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Dr. Stalmans Ingeborg, Universitaire Ziekenhuizen Leuven:
Cross sectional studies
Metabolomics
Glaucoma
Low tension glaucoma
Ophthalmologic surgical procedures

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases