Validation of Retinal Oximetry in Glaucoma Patients: a Structural and Functional Correlation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT01391247

First received: June 28, 2011

Last updated: February 5, 2013

Last verified: December 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

June 28, 2011

Last Updated Date

February 5, 2013

Start Date ^ICMJE

January 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Comparison of oxygen saturation between glaucoma patients and healthy controls. [ Time Frame: patients will be followed during their hospital stay, an average. of 3 hours ] [ Designated as safety issue: No ]

Retinal oximetry gives us oxygen saturation values who will be compared between glaucoma patients and healthy controls and will be correlated to visual field mean defect, structure parameters from the HRT and velocity measurements with the CDI.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01391247 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Validation of Retinal Oximetry in Glaucoma Patients: a Structural and Functional Correlation

Official Title ^ICMJE

Validation of Retinal Oximetry in Glaucoma Patients: a Structural and Functional Correlation

Brief Summary

Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Up until today, very little is known about the metabolic alterations in the retina of glaucoma patients, since only techniques for surrogate measurements of metabolism (like blood flow velocities and vessel diameter) were available. Oximetry has provided us with an important tool to study metabolism in glaucoma, and to correlate these findings with the available blood flow evaluation techniques. Preliminary results by the group of Prof Stefánsson (2011) with the dual wavelength oximeter pointed out that deeper glaucomatous visual field defects are associated with decreased arteriovenous differences in retinal oxygen saturation. These data suggest that a change in oxygen metabolism occurs in glaucomatous retina. This reduced oxygen metabolism may be related to tissue atrophy. However, this explanation is still hypothetical, since the relation between these oximetry results and structural changes in the optic nerve have not been studied yet.

What are the oximetry values in a normal population of within the same age group as the glaucoma population? To answer this question, a normative database of the investigators retinal oximetry device needs to be constructed for healthy controls.
Do glaucoma patients have different retinal oximetry values than these normal patients? Are there any differences in retinal oxygenation between these glaucoma groups? To answer these questions, oximetry measurements will be performed in patients with normal tension glaucoma (NTG) and primary open angle glaucoma (POAG).
Is there an association between structural optic disc and retinal nerve fibre layer changes, using Heidelberg Retinal Tomography (HRT), with alterations in retinal vascular oxygen saturation in NTG and POAG patients?
Are blood flow measurements, using colour Doppler imaging (CDI), correlated with alteration in retinal vascular oxygen in NTG and POAG patients?

Detailed Description

Oximetry pictures will be taken and analysed.
CDI exam will be performed.
Visual field examen will be performed.
HRT will be performed.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

primary care clinic

Condition ^ICMJE

Open Angle Glaucoma
Low Tension Glaucoma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

healthy age machted controls
normal tension glaucoma patients
primary open angle glaucoma patients

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

individuals over 18 years old
willing to sign an informed consent and able to comply with the requirements of the study
having no other ocular diseases besides glaucoma

Exclusion Criteria:

history of ocular trauma
intraocular surgery (except for cataract surgery)
eye disease (except glaucoma)
systemic diseases with ocular involvement like diabetes

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01391247

Other Study ID Numbers ^ICMJE

S52610

Has Data Monitoring Committee

Responsible Party

Universitaire Ziekenhuizen Leuven

Study Sponsor ^ICMJE

Universitaire Ziekenhuizen Leuven

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ingeborg Stalmans, MD, Phd

Universitaire Ziekenhuizen Leuven

Information Provided By

Universitaire Ziekenhuizen Leuven

Verification Date

December 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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