Pressure Difference Between Brain and Eye: a Possible Cause to Normal Tension Glaucoma.
Pathological Cerebral Venous Drainage System Giving Large Pressure Difference Between Brain and Eye at Upright Posture: a Possible Cause to Normal Tension Glaucoma.
1 other identifier
observational
17
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2016
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 16, 2016
CompletedFirst Posted
Study publicly available on registry
May 18, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedMay 3, 2017
May 1, 2016
4 months
May 16, 2016
May 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Trans-lamina cribrosa pressure difference (TLCPD)
Difference between intraocular pressure (IOP) and intracranial pressure in different body positions
1 day Single time point measurement
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)
1 day Single time point measurement
Other Outcomes (1)
Retinal perfusion using 3D Phase contrast magnetic resonance imaging (3DPCMRI)
1 day Single time point measurement
Study Arms (1)
Normal Tension Glaucoma
Patients with manifest normal tension glaucoma
Eligibility Criteria
Normal tension glaucoma patients
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
- Västerbotten County Council, Swedencollaborator
Study Sites (1)
Umeå University
Umeå, SE-901 85, Sweden
Related Publications (1)
Linden C, Qvarlander S, Johannesson G, Johansson E, Ostlund F, Malm J, Eklund A. Normal-Tension Glaucoma Has Normal Intracranial Pressure: A Prospective Study of Intracranial Pressure and Intraocular Pressure in Different Body Positions. Ophthalmology. 2018 Mar;125(3):361-368. doi: 10.1016/j.ophtha.2017.09.022. Epub 2017 Oct 31.
PMID: 29096996DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Malm, MD
Umeå University
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2016
First Posted
May 18, 2016
Study Start
February 1, 2016
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
May 3, 2017
Record last verified: 2016-05