NCT02410148

Brief Summary

Glaucoma remains a disease with an unclear and complex underlying pathophysiology. Recently, researchers have emphasized not only intraocular pressure (IOP) or vascular dysregulation, but also translaminar pressure's (TPG) role in glaucoma (TPG=IOP-ICP). A higher TPG may lead to abnormal function and optic nerve damage due to changes in axonal transportation, deformation of the lamina cribrosa, altered blood flow, or a combination thereof leading to glaucomatous damage. However only invasive ICP measurements are available within the contemporary medicine. The ideas for non-invasive ICP measurement have been approached since about 1980. Most of the proposed technologies were based on ultrasound and were capable of monitoring blood flow in intracranial or intraocular vessels, cranium diameter, or acoustic properties of the cranium. Broad research has extended into sonography of optic nerve sheath and its relation with elevated ICP. However, most of these correlation-based methods had the same problem-the need of individual patient specific calibration. Seeking to measure absolute ICP values, researchers from Kaunas University of Technology created a non-invasive method, which does not need a patient specific calibration. The method is based on direct comparison of ICP value with the value of pressure Pe that is externally applied to the tissues surrounding the eyeball. Intracranial segment of ophthalmic artery (OA) is used as a natural sensor of ICP and extracranial segment of OA is used as a sensor of Pe. The special two depth transcranial Doppler (TCD) device is used as a pressure balance indicator when ICP = Pe. The aim of our study is to assess TPG in patients with primary open open-angle glaucoma (POAG). In addition the investigators want to measure ICP in patients with papilledema (PE) in order to compare them with glaucoma patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 7, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

1.3 years

First QC Date

March 23, 2015

Last Update Submit

April 7, 2015

Conditions

Open-angle GlaucomaPapilledema

Keywords

open-angle glaucomapapilledemanon-invasive ICPIntracranial pressure

Outcome Measures

Primary Outcomes (1)

  • TPG (Translaminar Pressure Gradiant)

    TPG= (IOP-ICP)

    Day 1

Secondary Outcomes (5)

  • Arterial blood pressure

    Day 1

  • MD (Mean Deviation) in Visual Field

    Day 1

  • Average RNFL (retinal nerve fiber layer) thickness

    Day 1

  • BCVA (best corrected visual acuity)

    Day 1

  • Adverse Events

    Day 14 (+/- 4 days)

Study Arms (2)

Papilledema

ACTIVE COMPARATOR

non-invasive aICP measurement in patientes with papilledema

Device: Non-invasive ICP measurement (Vittamed 305)

open angle glaucoma

ACTIVE COMPARATOR

non-invasive aICP measurement in patients with glaucoma

Device: Non-invasive ICP measurement (Vittamed 305)

Interventions

Non-invasive ICP measurement (Vittamed 305)DEVICE

The non-invasive method is based on two-depth TCD technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA).

Papilledemaopen angle glaucoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with diagnosed POAG or PE
  • Age: ≥18 years at admission
  • Informed consent

You may not qualify if:

  • Patients with wounds, scars including the front orbital region.
  • Intraocular pressure range bellow 12 or above 25 mmHg
  • \> As the aim of the study is to analyze the role of TPG in the progression of POAG and PE, the study focusses on patients with normal IOP (12-25 mmHg)
  • Patients with any known ocular condition that - according to an Ophthalmologist - may be worsened by sustained eye pressure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kantonsspital Aarau

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

MeSH Terms

Conditions

Glaucoma, Open-AnglePapilledema

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesOptic Nerve DiseasesCranial Nerve DiseasesNervous System Diseases

Study Officials

  • Hanspeter Killer, MD

    Department of Ophthalmology, Kantonsspital Aarau, Aarau, Switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asan Kochkorov, MD

CONTACT

0041 62 838 92 03asan.kochkorov@ksa.ch

NeuroReserachOffice

CONTACT

0041 62 838 92 03nro@ksa.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 23, 2015

First Posted

April 7, 2015

Study Start

April 1, 2015

Primary Completion

July 1, 2016

Study Completion

March 1, 2017

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

CH(1)