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Completed

NCT Number: NCT02776449

Pressure Difference Between Brain and Eye: a Possible Cause to Normal Tension Glaucoma.

The main aim of this study is to determine the trans-laminal cribrosa pressure difference (TLCPD) for normal tension glaucoma (NTG) patients from the brain and the eye in supine, upright and minor head down tilt positions. It is also to investigate the venous drainage system in the same body positions.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Umeå University

Umeå, SE-901 85, Sweden

About this study

The trans-lamina cribrosa pressure difference (TLCPD), i.e. the difference between the intraocular pressure (IOP) and the intracranial pressure (ICP) has been suggested as a pathophysiological component in glaucoma. The theory is that high TLCPD, either due to elevated IOP or reduced ICP, can cause glaucomatous damage.

Normal tension glaucoma (NTG) patients has been found to have a slightly reduced ICP when measured in horizontal position. However, in a previous study in healthy adult volunteers the investigators have measured TLCPD at supine, sitting and 9 degree head down tilt positions and found that the TLCPD was posture dependent, with the largest difference in the upright position. Since humans are upright approximately two thirds of the day, one can expect that TLCPD in a diurnal perspective is primarily influenced by the ICP in the upright position.

In this study the TLCPD in different positions in patients with NTG will therefore be measured.

The study will be carried out in three parts.

  • TLCPD will be investigated by simultaneous measurements of IOP and ICP. For IOP the Applanation resonance tonometer (ART), developed by our research group, will be used. ART is independent of gravitation and possible to use in all body postures. In this study measurements will be performed in supine, sitting and head down tilt positions. ICP is measured continuously during the period of body position changes with a CELDA lumbar pressure measurement apparatus.
  • Brain and eye MRI investigation will be performed at a 3 Tesla GE scanner with a new generation 32-channels head coil. The images will be used to measure the cross-section area, the blood flow velocity and the flow direction in the jugular veins, as well as the structural properties of the optic nerve and optic nerve head.
  • Ultrasound imaging, using a high-resolution apparatus, will be performed to study the effects of postural changes on the blood flow velocity and the cross-section area of the right and left internal jugular veins and external jugular veins.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject has normal tension glaucoma in one or both eyes (glaucomatous optic nerve head and corresponding visual field defects)
  • Intraocular pressures before treatment did not exceed 21 mmHg. Occasional measurement up to 24 is accepted.

Exclusion criteria

  • History of brain disease or brain surgery
  • History of other neurologic or ocular disease causing visual field loss
  • Use of anticoagulants other than acetylsalicylic acid
  • Use of carbonic anhydrase inhibitors
  • Previous lumbar puncture
  • Claustrophobia

Treatment and study plan

Primary outcomes

  1. Trans-lamina cribrosa pressure difference (TLCPD)

    Time frame: 1 day Single time point measurement

    Difference between intraocular pressure (IOP) and intracranial pressure in different body positions

Secondary outcomes

  1. Postural changes on blood flow velocity and cross-section area of right and left internal jugular veins (IJV) and external jugular veins (EJV)

    Time frame: 1 day Single time point measurement

Other outcomes

  1. Retinal perfusion using 3D Phase contrast magnetic resonance imaging (3DPCMRI)

    Time frame: 1 day Single time point measurement

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Västerbotten County Council, Sweden

Registry information

Official study title

Pathological Cerebral Venous Drainage System Giving Large Pressure Difference Between Brain and Eye at Upright Posture: a Possible Cause to Normal Tension Glaucoma.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 18, 2016
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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