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

NCT01391247 | Completed

• 1 other identifier: S52610
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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

Conditions

Open Angle Glaucoma; Low Tension Glaucoma

Keywords

open angle glaucoma; low tension glaucoma; oximetry

Outcome Measures

Primary Outcomes (1)

• Comparison of oxygen saturation between glaucoma patients and healthy controls.

  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.

  patients will be followed during their hospital stay, an average. of 3 hours

Study Arms (3)

healthy age machted controls

normal tension glaucoma patients

primary open angle glaucoma patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

primary care clinic

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

Department of Ophthalmology, UZLeuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Officials

• Ingeborg Stalmans, MD, Phd

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: July 11, 2011
• Study Start: January 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 6, 2013

Record last verified: 2010-12

Locations

BE (1)