Metabolomics in Surgical Ophthalmological Patients

NCT03098316 | Unknown DMC

• 1 other identifier: MISO Study
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Open-angle Glaucoma; Low Tension Glaucoma

Keywords

Cross sectional studies; Metabolomics; Glaucoma; Low tension glaucoma; Ophthalmologic surgical procedures

Outcome Measures

Primary Outcomes (1)

• Metabolomics profile of each group

  un-targeted metabolomics and identification of metabolites based on exact mass using metabolomics library

  Morning of the surgery

Secondary Outcomes (1)

• Surgical success of glaucoma patients

  12 months

Study Arms (3)

POAG

Primary open angle glaucoma patients

Diagnostic Test: Metabolomics analysis of patient samples

NTG

Normal/Low tension glaucoma patients

Diagnostic Test: Metabolomics analysis of patient samples

Control

Patients with cataract and without glaucoma or other eye diseases

Diagnostic Test: Metabolomics analysis of patient samples

Interventions

Metabolomics analysis of patient samples DIAGNOSTIC_TEST

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

Control; NTG; POAG

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the ophthalmology department that are undergoing intraocular surgery.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• FRO (Funds for Research in Ophthalmology, Belgium): collaborator

Study Sites (1)

University Hospitals Leuven

Leuven, Leuven, 3000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma, urine, aqueous humor

MeSH Terms

Conditions

Glaucoma, Open-Angle; Low Tension Glaucoma; Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Ingeborg Stalmans, MD, PhD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sien Boons

CONTACT

003216340391; sien.boons@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the glaucoma department

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: March 31, 2017
• Study Start: January 31, 2017
• Primary Completion: September 30, 2017
• Study Completion: September 30, 2018
• Last Updated: April 4, 2017

Record last verified: 2017-03

Locations

BE (1)