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

Open Angle Glaucoma Clinical Trial

Official title:

Correlation Between Retinal Metabolism and the Observation of a Visible Retinal Spontaneous Venous Pulse

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01794442
• Other study ID #: S120213
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2013
• Last updated: May 28, 2015
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: January 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Low Tension Glaucoma
• Normal Tension Glaucoma
• Open Angle Glaucoma

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 3 months	No