Intraocular PressureNCT02558309
Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure
An observational study of Intraocular Pressure and Intracranial Hypertension, run by NYU Langone Health.
Trial summary
The goal of this study is to examine in-vivo the effect of intraocular (IOP) and intracranial pressures (ICP) on the optic nerve head (ONH). The effect of ICP on eye health has been an area of concrete research effort in recent years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intraocular Pressure, Intracranial Hypertension
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are scheduled to undergo gradual, step-wise reduction of Intracranial Pressure (ICP) will be screened.
Who may be able to join
- Age 18 and older.
- Patients with an external ventricular drain (EVD).
- Normally appearing eye as determined during the screening clinical examination.
Who cannot join
- History of intraocular surgery or ocular trauma (with the exception of laser procedures or uneventful cataract surgery more than 1 year from enrollment date).
- Ocular disorders that could affect retinal function such as retinal detachment, diabetic retinopathy, Macular degeneration.
- Neurological \& Non-Glaucomatous causes for Visual Field damage.
About this study
The goal of this study is to examine in-vivo the effect of intraocular (IOP) and intracranial pressures (ICP) on the optic nerve head (ONH). The effect of ICP on eye health has been an area of concrete research effort in recent years. The ability to acquire non-invasive and highly detailed information on both the eye and the brain using technologies such as magnetic resonance imaging (MRI) and optical coherence tomography (OCT) have paved the way to assess non-invasively the effect of ICP in-vivo. In this study, we will quantify the structural changes in the ONH in subjects with elevated ICP while they are treated to reduce the elevated pressure. This process will occur in a stepwise fashion over a period of time determined by the clinical treatment plans. We will apply controlled pressures to the eye during each step of ICP lowering while OCT images are obtained.
Read the detailed description
Objective:
The goal of this study is to examine in-vivo the effect of intraocular (IOP) and intracranial pressures (ICP) on the optic nerve head (ONH).
Specific Aims:
In this study, the investigators will quantify the structural changes in the ONH in subjects with elevated ICP while they are treated to reduce the elevated pressure. This process will occur in a stepwise fashion over a period of time determined by the clinical treatment plans. The investigators will apply controlled pressures to the eye during each step of ICP lowering while OCT images are obtained.
Background:
The effect of ICP on eye health has been an area of concrete research effort in recent years. The ability to acquire non-invasive and highly detailed information on both the eye and the brain using technologies such as magnetic resonance imaging (MRI) and optical coherence tomography (OCT) have paved the way to assess non-invasively the effect of ICP in-vivo.
The ONH separates two pressurized compartments: the eyeball and the central nervous system. Situations in which ICP is elevated are often associated with papilledema, though the magnitude and the rate of change in ONH elevation in response to increased ICP or the reduction in ONH elevation in response to ICP treatments are yet to be determined. On the opposite side, glaucoma is a leading cause of blindness where elevated IOP is the leading risk factor, with clinical evidence suggesting the presence of ICP below the normal level in these subjects. The impaired balance between IOP and ICP leads to the deformation of the ONH, which triggers strangulation of the retinal ganglion cell axons when trespassing through the lamina cribrosa within the ONH on their way from the eye to the brain, leading to gradual axonal loss and irreversible visual impairment.
Significance:
Little is known about how the interaction of IOP and ICP pressure changes affect the macrostructure and microstructure of the optic nerve head structure. This information has a significant impact both for neurosurgical conditions with elevated ICP along with ocular conditions such as glaucoma and papilledema. The ability to gauge non-invasively changes in ICP will have a tremendous impact on neurosurgical management as it eliminates the need of longitudinal invasive measurements of ICP. The study will also improve the investigator's understanding of the pathophysiologic processes that lead to development of glaucoma as well as the response to treatment for subjects with papilledema. A better understanding of these processes will ultimately lead to improved detection and management of these conditions and a better understanding of ocular bio-mechanics.
- Conditions
- Intraocular Pressure, Intracranial Hypertension
- Medical subject headings
- Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intracranial Pressure Reduction | Subjects scheduled to undergo gradual, step-wise reduction of Intracranial Pressure (ICP) will be screened. * The Glasgow Coma Scale will be administered to ascertain the cognitive ability of the participant. * A slit lamp examination and indirect ophthalmoscopy will be performed. Experimental: * The subject's eye will be held open with an eye speculum during the exam. * Another eye exam, which includes a slit lamp examination and indirect ophthalmoscopy, will be performed. * Intraocular Pressure will be measured. * An Optic Coherence Tomography (OCT) will be performed. * At each step along the process of ICP reduction, the eye exam, IOP \& OCT will be performed. Optional: * The Ophthalmology study team will raise the IOP using an Ophthlmodynanometer. It will be raised to 20 mmHg and 40 mmHg while OCT scans are obtained. * OCT scans will be taken at pre-manipulation, 20mmHg, 40mmHg, and post-manipulation at each step of the ICP lowering procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optic Nerve Head
The optic nerve head (ONH) structures will be evaluated for tissue deformation. The association between the structural findings in the optic nerve head region and intracranial and intraocular pressures will be evaluated.
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: The Primary Investigator is no longer with UPMC. No patients have been enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gadi Wollstein, MD, Principal investigator, University of Pittsburgh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02558309
- Sponsor's protocol ID
- PRO15070113
- Status last verified
- Jan 2017
- First submitted
- 22 Sep 2015
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Head Quantification While Reducing Elevated Intracranial Pressure
- ClinicalTrials.gov ID
- NCT02558309
- Acronym / sponsor ID
- PRO15070113
- Conditions
- Intraocular Pressure, Intracranial Hypertension
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The Primary Investigator is no longer with UPMC. No patients have been enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to examine in-vivo the effect of intraocular (IOP) and intracranial pressures (ICP) on the optic nerve head (ONH). The effect of ICP on eye health has been an area of concrete research effort in recent years. The ability to acquire non-invasive and highly detailed information on both the eye and the brain using technologies such as magnetic resonance imaging (MRI) and optical coherence tomography (OCT) have paved the way to assess non-invasively the effect of ICP in-vivo. In this study, we will quantify the structural changes in the ONH in subjects with elevated ICP while they are treated to reduce the elevated pressure. This process will occur in a stepwise fashion over a period of time determined by the clinical treatment plans. We will apply controlled pressures to the eye during each step of ICP lowering while OCT images are obtained.
Detailed description
Objective:
The goal of this study is to examine in-vivo the effect of intraocular (IOP) and intracranial pressures (ICP) on the optic nerve head (ONH).
Specific Aims:
In this study, the investigators will quantify the structural changes in the ONH in subjects with elevated ICP while they are treated to reduce the elevated pressure. This process will occur in a stepwise fashion over a period of time determined by the clinical treatment plans. The investigators will apply controlled pressures to the eye during each step of ICP lowering while OCT images are obtained.
Background:
The effect of ICP on eye health has been an area of concrete research effort in recent years. The ability to acquire non-invasive and highly detailed information on both the eye and the brain using technologies such as magnetic resonance imaging (MRI) and optical coherence tomography (OCT) have paved the way to assess non-invasively the effect of ICP in-vivo.
The ONH separates two pressurized compartments: the eyeball and the central nervous system. Situations in which ICP is elevated are often associated with papilledema, though the magnitude and the rate of change in ONH elevation in response to increased ICP or the reduction in ONH elevation in response to ICP treatments are yet to be determined. On the opposite side, glaucoma is a leading cause of blindness where elevated IOP is the leading risk factor, with clinical evidence suggesting the presence of ICP below the normal level in these subjects. The impaired balance between IOP and ICP leads to the deformation of the ONH, which triggers strangulation of the retinal ganglion cell axons when trespassing through the lamina cribrosa within the ONH on their way from the eye to the brain, leading to gradual axonal loss and irreversible visual impairment.
Significance:
Little is known about how the interaction of IOP and ICP pressure changes affect the macrostructure and microstructure of the optic nerve head structure. This information has a significant impact both for neurosurgical conditions with elevated ICP along with ocular conditions such as glaucoma and papilledema. The ability to gauge non-invasively changes in ICP will have a tremendous impact on neurosurgical management as it eliminates the need of longitudinal invasive measurements of ICP. The study will also improve the investigator's understanding of the pathophysiologic processes that lead to development of glaucoma as well as the response to treatment for subjects with papilledema. A better understanding of these processes will ultimately lead to improved detection and management of these conditions and a better understanding of ocular bio-mechanics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intracranial Pressure Reduction | – | –Subjects scheduled to undergo gradual, step-wise reduction of Intracranial Pressure (ICP) will be screened. * The Glasgow Coma Scale will be administered to ascertain the cognitive ability of the participant. * A slit lamp examination and indirect ophthalmoscopy will be performed. Experimental: * The subject's eye will be held open with an eye speculum during the exam. * Another eye exam, which includes a slit lamp examination and indirect ophthalmoscopy, will be performed. * Intraocular Pressure will be measured. * An Optic Coherence Tomography (OCT) will be performed. * At each step along the process of ICP reduction, the eye exam, IOP \& OCT will be performed. Optional: * The Ophthalmology study team will raise the IOP using an Ophthlmodynanometer. It will be raised to 20 mmHg and 40 mmHg while OCT scans are obtained. * OCT scans will be taken at pre-manipulation, 20mmHg, 40mmHg, and post-manipulation at each step of the ICP lowering procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are scheduled to undergo gradual, step-wise reduction of Intracranial Pressure (ICP) will be screened.
Key inclusion criteria (3 listed)
- Age 18 and older.
- Patients with an external ventricular drain (EVD).
- Normally appearing eye as determined during the screening clinical examination.
Key exclusion criteria (3 listed)
- History of intraocular surgery or ocular trauma (with the exception of laser procedures or uneventful cataract surgery more than 1 year from enrollment date).
- Ocular disorders that could affect retinal function such as retinal detachment, diabetic retinopathy, Macular degeneration.
- Neurological \& Non-Glaucomatous causes for Visual Field damage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Optic Nerve Head
Time frame: 1 Week
The optic nerve head (ONH) structures will be evaluated for tissue deformation. The association between the structural findings in the optic nerve head region and intracranial and intraocular pressures will be evaluated.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gadi Wollstein, MD principal investigator
University of Pittsburgh Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure and Intracranial Hypertension, run by NYU Langone Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optic Nerve Head (time frame: 1 Week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.