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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

June 28, 2011
February 5, 2013
January 2011
December 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01391247 on ClinicalTrials.gov Archive Site
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Validation of Retinal Oximetry in Glaucoma Patients: a Structural and Functional Correlation
Validation of Retinal Oximetry in Glaucoma Patients: a Structural and Functional Correlation

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?
  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.
Observational
Time Perspective: Prospective
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Probability Sample

primary care clinic

  • Open Angle Glaucoma
  • Low Tension Glaucoma
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  • healthy age machted controls
  • normal tension glaucoma patients
  • primary open angle glaucoma patients
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT01391247
S52610
No
Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
Not Provided
Principal Investigator: Ingeborg Stalmans, MD, Phd Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
December 2010

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