Open Angle GlaucomaNCT01391247
Validation of Retinal Oximetry in Glaucoma Patients: a Structural and Functional Correlation
An observational study of Open Angle Glaucoma and Low Tension Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Open Angle Glaucoma, Low Tension Glaucoma
- How many people
- 59 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic
Who may be able to join
- 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
Who cannot join
- history of ocular trauma
- intraocular surgery (except for cataract surgery)
- eye disease (except glaucoma)
- systemic diseases with ocular involvement like diabetes
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the detailed description
- Oximetry pictures will be taken and analysed.
- CDI exam will be performed.
- Visual field examen will be performed.
- HRT will be performed.
- Conditions
- Open Angle Glaucoma, Low Tension Glaucoma
- Keywords
- open angle glaucoma, low tension glaucoma, oximetry
- Medical subject headings
- Glaucoma, Open-Angle, Low Tension Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy age machted controls | Not described | |
| normal tension glaucoma patients | Not described | |
| primary open angle glaucoma patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: patients will be followed during their hospital stay, an average. of 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingeborg Stalmans, MD, Phd, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391247
- Sponsor's protocol ID
- S52610
- Status last verified
- Dec 2010
- First submitted
- 28 Jun 2011
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Retinal Oximetry in Glaucoma Patients: a Structural and Functional Correlation
- ClinicalTrials.gov ID
- NCT01391247
- Acronym / sponsor ID
- S52610
- Conditions
- Open Angle Glaucoma, Low Tension Glaucoma
- Keywords
- open angle glaucoma, low tension glaucoma, oximetry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy age machted controls | – | – |
| normal tension glaucoma patients | – | – |
| primary open angle glaucoma patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- history of ocular trauma
- intraocular surgery (except for cataract surgery)
- eye disease (except glaucoma)
- systemic diseases with ocular involvement like diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ingeborg Stalmans, MD, Phd principal investigator
Universitaire Ziekenhuizen KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma and Low Tension Glaucoma, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2013.