NCT03098316: MISO

Metabolomics in Surgical Ophthalmological Patients

Status unknown Last updated 4 April 2017

What this trial tests

trial testing Metabolomics analysis of patient samples in Primary Open-angle Glaucoma in 90 participants. Status unknown.

Timeline

31 January 2017

Primary endpoint
30 September 2017

30 September 2018

Quick facts

Lead sponsor	Universitaire Ziekenhuizen KU Leuven
Status	Status unknown
Study type	OBSERVATIONAL
Enrollment	90
Start date	31 January 2017
Primary completion	30 September 2017
Estimated completion	30 September 2018
Sites	1 location across Belgium

Drugs / interventions tested

• Metabolomics analysis of patient samples

Conditions studied

• Primary Open-angle Glaucoma — all drugs for Primary Open-angle Glaucoma →
• Low Tension Glaucoma — all drugs for Low Tension Glaucoma →

Sponsor

Universitaire Ziekenhuizen KU Leuven — full company profile →

Who can join

Adults 60 to 90, any sex, with Primary Open-angle Glaucoma or Low Tension Glaucoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Metabolomic Analysis of Aqueous Humor to Predict Glaucoma Progression and Overall Survival After Glaucoma Surgery-The MISO II Study.
   Detremmerie L, Sava AC, Himmelreich U, Stalmans I, et al · · 2026 · PMID 41745583 · DOI 10.3390/metabo16020100