Metabolomics in Surgical Ophthalmological Patients

NCT ID: NCT03098316

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2018-09-30

Brief 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, 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.

Conditions

Primary Open-angle Glaucoma; Low Tension Glaucoma

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

POAG

Primary open angle glaucoma patients

Metabolomics analysis of patient samples

Intervention Type: DIAGNOSTIC_TEST

Metabolomics analysis of patient samples by mass spectrometry and nuclear magnetic resonance spectroscopy.

NTG

Normal/Low tension glaucoma patients

Metabolomics analysis of patient samples

Intervention Type: DIAGNOSTIC_TEST

Metabolomics analysis of patient samples by mass spectrometry and nuclear magnetic resonance spectroscopy.

Control

Patients with cataract and without glaucoma or other eye diseases

Metabolomics analysis of patient samples

Intervention Type: DIAGNOSTIC_TEST

Metabolomics analysis of patient samples by mass spectrometry and nuclear magnetic resonance spectroscopy.

Interventions

Metabolomics analysis of patient samples

Metabolomics analysis of patient samples by mass spectrometry and nuclear magnetic resonance spectroscopy.

Intervention Type: DIAGNOSTIC_TEST

Eligibility 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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

FRO (Funds for Research in Ophthalmology, Belgium)

UNKNOWN

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Stalmans Ingeborg

Head of the glaucoma department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ingeborg Stalmans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitaire Ziekenhuizen KU Leuven

Locations

University Hospitals Leuven

Leuven, Leuven, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Sien Boons

Role: CONTACT

sien.boons@uzleuven.be

003216340391

Facility Contacts

Sien Boons

Role: primary

003216340391

Other Identifiers

MISO Study

Identifier Type: -

Identifier Source: org_study_id