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aICP in Glaucoma and Papilledema (aICP Ophtha)

Primary Purpose

Open-angle Glaucoma, Papilledema

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Non-invasive ICP measurement (Vittamed 305)
Sponsored by
Kantonsspital Aarau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Open-angle Glaucoma focused on measuring open-angle glaucoma, papilledema, non-invasive ICP, Intracranial pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Kantonsspital AarauRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Papilledema

open angle glaucoma

Arm Description

non-invasive aICP measurement in patientes with papilledema

non-invasive aICP measurement in patients with glaucoma

Outcomes

Primary Outcome Measures

TPG (Translaminar Pressure Gradiant)
TPG= (IOP-ICP)

Secondary Outcome Measures

Arterial blood pressure
MD (Mean Deviation) in Visual Field
Average RNFL (retinal nerve fiber layer) thickness
BCVA (best corrected visual acuity)
Adverse Events

Full Information

First Posted
March 23, 2015
Last Updated
April 7, 2015
Sponsor
Kantonsspital Aarau
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1. Study Identification

Unique Protocol Identification Number
NCT02410148
Brief Title
aICP in Glaucoma and Papilledema
Acronym
aICP Ophtha
Official Title
Non-invasive Absolute Intracranial Pressure (ICP) Measurement in Patients With Open-angle Glaucoma and Papilledema
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
March 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kantonsspital Aarau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Glaucoma is a progressive optic neuropathy leading to the retinal ganglion cell death and typical optic nerve head (ONH) damage [1]. It remains a disease with an unclear and complex underlying pathophysiology. Intraocular pressure (IOP) is the main and only modifiable risk factor for glaucoma [2]. Although lowering IOP helps to decelerate or stabilize the disease, a vast number of patients still show signs of glaucoma despite an IOP within normal range. Clearly other pathogenetic mechanisms beyond IOP are involved in the pathogenesis of glaucoma for certain individuals. Non-IOP factors such as lower systolic ocular perfusion pressure (OPP), reduced ocular blood flow, cardiovascular disease, and low systolic blood pressure (BP) have been identified as risk factors for primary open-open-angle glaucoma (POAG) [3-6]. Evidence shows that non-IOP factors can impact the apoptotic process associated with glaucoma [7]. Recently, researchers have emphasized not only IOP or vascular dysregulation, but also intracranial pressure's (ICP) role in glaucoma [8-10]. The optic nerve is exposed not only to IOP in the eye, but also to ICP as it is surrounded by cerebrospinal fluid (CSF) in the subarachnoid space. Because the lamina cribrosa separates these two pressurized regions [11], the decrease in pressure that occurs across the lamina cribrosa (IOP-ICP) is known as the translaminar pressure gradient (TPG). 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. Besides, TPG may be the primarily pressure-related parameter for glaucoma [12-15], since the ONH is located at the junction between the intraocular space and the orbital retrobulbar space. However, the role of TPG still remains unknown, because only invasive ICP measurements are available within the contemporary medicine (lumbar puncture or punction of brain ventricles-for patients with severe brain injury). The ideas for noninvasive ICP measurement have been appearing since about 1980. Numerous methods for finding the objects or physiological characteristics of cerebrospinal system that would be related to the ICP and its monitoring have been sought by many authors. 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 [16]. Broad research has extended into sonography of optic nerve sheath and its relation with elevated ICP [17]. 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 noninvasive method, which does not need a patient specific calibration [18, 19]. 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. A special two depth transcranial Doppler (TCD) device [18, 19] is used as a pressure balance indicator when ICP = Pe. Accuracy, precision, sensitivity, specificity, and diagnostic value of this method were proven with healthy subjects and patients with neurological diseases. This device has not yet been used in clinical studies to investigate TPG significance in glaucoma. 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. The non-invasive ICP measurement using two deeps TCD device allows us to get ICP values from immediate vicinity of optic nerve, which in turn very important in term of understanding the pathophysiology of such conditions like PE and POAG.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, Papilledema
Keywords
open-angle glaucoma, papilledema, non-invasive ICP, Intracranial pressure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Papilledema
Arm Type
Active Comparator
Arm Description
non-invasive aICP measurement in patientes with papilledema
Arm Title
open angle glaucoma
Arm Type
Active Comparator
Arm Description
non-invasive aICP measurement in patients with glaucoma
Intervention Type
Device
Intervention Name(s)
Non-invasive ICP measurement (Vittamed 305)
Intervention Description
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).
Primary Outcome Measure Information:
Title
TPG (Translaminar Pressure Gradiant)
Description
TPG= (IOP-ICP)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Arterial blood pressure
Time Frame
Day 1
Title
MD (Mean Deviation) in Visual Field
Time Frame
Day 1
Title
Average RNFL (retinal nerve fiber layer) thickness
Time Frame
Day 1
Title
BCVA (best corrected visual acuity)
Time Frame
Day 1
Title
Adverse Events
Time Frame
Day 14 (+/- 4 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with diagnosed POAG or PE Age: ≥18 years at admission Informed consent Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Asan Kochkorov, MD
Phone
0041 62 838 92 03
Email
asan.kochkorov@ksa.ch
First Name & Middle Initial & Last Name or Official Title & Degree
NeuroReserachOffice
Phone
0041 62 838 92 03
Email
nro@ksa.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hanspeter Killer, MD
Organizational Affiliation
Department of Ophthalmology, Kantonsspital Aarau, Aarau, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kantonsspital Aarau
City
Aarau
State/Province
Aargau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asan Kochkorov, MD
Phone
+41 62 838 92 03
Email
nro@ksa.ch

12. IPD Sharing Statement

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aICP in Glaucoma and Papilledema

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