Correlation of Orbital Cerebrospinal Fluid Pressure and Retinal Venous Outflow in Primary Open-angle Glaucoma

NCT ID: NCT01795014

Last Updated: 2013-02-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-04-30

Brief Summary

A spontaneous venous pulsation over the optic disc is an ophthalmological sign that can potentially be found in up to 98% of healthy individuals. In fact, the lack of this spontaneous retinal venous pulse has been consistently implicated as an indicator of a more advanced form of certain ocular diseases, specifically open-angle glaucoma. However, the mechanisms behind these change in the retinal venous system are not clear. Some evidence suggests that extraocular features such as intracranial pressure (ICP) may play a role in regulating the intraocular venous outflow. The reasons for this hypothetical downstream resistance to venous outflow are not fully understood, with advances in this field being limited by our technological-imposed difficulties in assessing the structures behind the globe.

However, it has been established that the volume of cerebrospinal fluid surrounding the optic nerve correlates with the ICP at the orbital level. Recent studies have suggested that non-invasive ultrasound-based recordings have correlated this surrogate for orbital ICP with the intraocular pressure (IOP) in glaucoma patients with an otherwise normal IOP range (normal tension glaucoma - NTG).

The investigators will therefore conduct a test to determine if this cerebrospinal volume surrounding the optic nerve correlates with the frequency of observation of an otherwise signal of venous dysfunction (i.e. the lack of a visible pulse in the retinal central vein) Additionally, the investigators will assess if this correlation is different between healthy individuals, hypertensive primary-open angle glaucoma or NTG patients.

Detailed Description

1. Spontaneous venous pulsation will be recorded after a one minute fundoscopy observation.

2. B-mode ultrasound of the orbit will be performed and the optic nerve sheath diameter measured 3mm behind the globe

3. Visual field examination will be performed.

4. Structural examination of the optic disc (confocal microscopy) will be performed.

Conditions

Primary Open Angle Glaucoma; Normal Tension Glaucoma

Study Design

• Study Time Perspective: PROSPECTIVE

Study Groups

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 IOP above 21 mmHg that could suggest possible glaucoma suspects.

No interventions assigned to this group

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

No interventions assigned to this group

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

No interventions assigned to this group

Eligibility 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 or graves ophthalmopathy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingeborg Stalmans, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

KU Leuven

Leuven, Flemish Brabant, Belgium

Site Status: RECRUITING

Countries

Belgium

Facility Contacts

Evelien Vandewalle, Md, PhD

Role: primary

eve_vandewalle@hotmail.com

Other Identifiers

SVP0002

Identifier Type: -

Identifier Source: org_study_id