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

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. Read our disclaimer for details. Identifier: NCT01391247
Recruitment Status : Completed
First Posted : July 11, 2011
Last Update Posted : February 6, 2013
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

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.

  1. 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.
  2. 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).
  3. 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?
  4. Are blood flow measurements, using colour Doppler imaging (CDI), correlated with alteration in retinal vascular oxygen in NTG and POAG patients?

Condition or disease
Open Angle Glaucoma Low Tension Glaucoma

Detailed Description:
  1. Oximetry pictures will be taken and analysed.
  2. CDI exam will be performed.
  3. Visual field examen will be performed.
  4. HRT will be performed.

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Study Type : Observational
Actual Enrollment : 59 participants
Time Perspective: Prospective
Official Title: Validation of Retinal Oximetry in Glaucoma Patients: a Structural and Functional Correlation
Study Start Date : January 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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

Primary Outcome Measures :
  1. 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 ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
primary care clinic

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

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 identifier (NCT number): NCT01391247

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Department of Ophthalmology, UZLeuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Ingeborg Stalmans, MD, Phd Universitaire Ziekenhuizen Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01391247     History of Changes
Other Study ID Numbers: S52610
First Posted: July 11, 2011    Key Record Dates
Last Update Posted: February 6, 2013
Last Verified: December 2010
Keywords provided by Universitaire Ziekenhuizen Leuven:
open angle glaucoma
low tension glaucoma
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases