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Status unknownNCT01794442Updated May 29, 2015

Study on the Oxygen Saturation in Pulsating and Non-pulsating Central Retinal Veins

An observational study in Open Angle Glaucoma and Normal Tension Glaucoma, sponsored by Universitaire Ziekenhuizen KU Leuven. Status unknown at 1 site in Belgium. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-29.

Sponsored by Universitaire Ziekenhuizen KU Leuven · Observational

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study summary

Retinal ischemia is thought to play an important role in the pathogenesis of glaucoma. Recent findings have confirmed that there is a direct correlation between the levels of venous oxygen saturation and the degree of the glaucomatous disease, presumably due to a decrease in retinal cell metabolism.

However, glaucoma patients have been suggested to have a different pattern in retinal venous circulation. For instance, the observation of a visible pulsating central retinal vein is a phenomenon that can be seen in up to 98% of the healthy individuals but is identifiable in less than 50% of glaucoma patients. While the nature of these venous changes are not year clear, the lack of a visible pulsating flow could suggest an increased intraluminal venous pressure due to some obstruction from both ocular or extraocular structures. This undetermined increase in venous pulse pressure could then significantly decrease perfusion pressures and therefore further decrease oxygen supply to the retinal tissues.

The investigators will therefore try to determine if there is a significant difference between the oxygen saturation of the retinal vessels in both glaucoma patients with and without a visible pulsating central vein

Read the detailed description
  1. Visual field examen will be performed.
  2. Structural examination of the optic disc (confocal microscopy) will be performed.
  3. Spontaneous venous pulsation will be recorded after a one minute fundoscopy observation.
  4. Oximetry reading in the non-contact retinal oximetry of the first 3 order retinal vessels
02

Conditions studied

  • Open Angle Glaucoma
  • Normal Tension Glaucoma
03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 120 is above the median of 103 across 454 observational studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Universitaire Ziekenhuizen KU Leuven is the lead sponsor of 928 studies on the registry; 261 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • history of ocular trauma
  • intraocular surgery (except for cataract surgery)
  • eye disease (except glaucoma)
  • systemic diseases with ocular involvement like diabetes
05

Study design

Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • Controls

    Healthy volunteers with no family history of glaucoma, an increased or asymmetrical cup/disc ratio or any other optic disc structural change (notching, disc hemorrhage) or an intraocular pressure (IOP) above 21 mmHg that could suggest possible glaucoma suspects.

  • Primary open-angle glaucoma

    Patients with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at least one measurement of IOP of \>21 mmHg required

  • Normal Tension Glaucoma

    Patients with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at maximum recorded IOP of \< 21 mmHg

06

What researchers measure

Primary outcomes

  1. Retinal Oxygen saturation in retinal veins with absent pulsation

    We will assess, through analysing the oximetry recordings from both pulsating and non-pulsating retinal veins, whether there are any differences in venous or arterial-venous oxygen saturation in primary open-angle glaucoma patients

    Time frame: Up to 3 months

07

Study locations

1 of 1 sites recruiting
  • UZ Leuven
    Leuven, Vlaams-Brabant 3000 Leuven, Belgium
    • Luis Pinto, MD, PhD · Contact · luis.pinto@uzleuven.be
    • Ingeborg Stalmans, MD, PhD · Principal investigator
    • Evelien Vandewalle, MD, PhD · Sub investigator
    • Luis Pinto, MD, PhD · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01794442
Lead sponsor
Universitaire Ziekenhuizen KU Leuven
Responsible party
Sponsor
First posted
Feb 18, 2013
Start date
Jan 2013
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
May 29, 2015

Study contacts

Ingeborg Stalmans, ND, PhD
principal investigator · UZ Leuven

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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