Trial record 12 of 949 for:    "Glaucoma"

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
  Purpose

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
Open Angle Glaucoma
Low Tension Glaucoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validation of Retinal Oximetry in Glaucoma Patients: a Structural and Functional Correlation

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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.


Enrollment: 59
Study Start Date: January 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
healthy age machted controls
normal tension glaucoma patients
primary open angle glaucoma patients

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

primary care clinic

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391247

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

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01391247     History of Changes
Other Study ID Numbers: S52610
Study First Received: June 28, 2011
Last Updated: February 5, 2013
Health Authority: Belgium: Ethics Committee

Keywords provided by Universitaire Ziekenhuizen Leuven:
open angle glaucoma
low tension glaucoma
oximetry

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Low Tension Glaucoma
Ocular Hypertension
Eye Diseases
Optic Nerve Diseases

ClinicalTrials.gov processed this record on August 26, 2014