Study on Ocular Blood Flow and the Orbital Cerebrospinal Fluid Pressure in Glaucoma

NCT01802463 | Completed

• 1 other identifier: S130213
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 1

Brief Summary

Ocular blood flow has been consistently demonstrated to be altered in glaucoma patients when compared to otherwise healthy individuals. Numerous Doppler studies have shown a decrease in flow velocities in the retrobulbar arteries in what appears to be related to the degree of the glaucomatous disease. The anatomic pathway of the several arteries into the eye is intricately complicate, with at least one of them (the central retina artery) penetrating the optic nerve before entering the eye and supplying the innermost structures of the globe. As the optic nerve is surrounded by a layer of cerebrospinal fluid (CSF) which is in continuity with the rest of the central nervous system, this central retinal artery has also to cross this CSF containing compartment. Because of the intrinsic pressure this CSF - corresponding to the intracranial pressure at the orbital level - the possibility exists that this pressure around the optic disc could affect the blood flow of the arteries that go through it. The investigators will try to detect if a correlation exists between the optic nerve sheath diameter and the blood flow in the retrobulbar vessels of glaucoma patients.

Conditions

Open Angle Glaucoma; Normal Tension Glaucoma

Outcome Measures

Primary Outcomes (1)

• Flow velocity of retrobulbar vessels

  Participants will be followed for the duration of hospital stay, an expected average of 2 hours

Study Arms (3)

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

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 clinic care

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)

KU Leuven

Leuven, Flemish Brabant, 3000 Leuven, Belgium

Location

Related Publications (1)

• Willekens K, Abegao Pinto L, Vandewalle E, Marques-Neves C, Stalmans I. Higher optic nerve sheath diameters are associated with lower ocular blood flow velocities in glaucoma patients. Graefes Arch Clin Exp Ophthalmol. 2014 Mar;252(3):477-83. doi: 10.1007/s00417-013-2533-y. Epub 2013 Nov 27.

  PMID: 24281785 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Low Tension Glaucoma

Condition Hierarchy (Ancestors)

Glaucoma; Ocular Hypertension; Eye Diseases; Optic Nerve Diseases

Study Design

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

Study Record Dates

• First Submitted: February 15, 2013
• First Posted: March 1, 2013
• Study Start: January 1, 2013
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 3, 2014

Record last verified: 2013-01

Locations

BE (1)