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Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus

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ClinicalTrials.gov Identifier: NCT03560609
Recruitment Status : Recruiting
First Posted : June 18, 2018
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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Brief Summary:

The mechanism by which vision loss in glaucoma occurs is still unknown, but it is clear that increased Intraocular Pressure (IOP) is a major risk factor. It is also thought that the lamina cribrosa (LC) is a site of primary damage during the pathogenesis of the disease. The changes caused by intraocular pressure (IOP) modulation at the level of the optic nerve head and LC will be evaluated in the present study. Subjects with keratoconus exhibit abnormal collagen properties that can impair their LC behavior. By evaluating their lamina biomechanical response we can advance our understanding on the role of the lamina in glaucoma pathogenesis. A better understanding of the process will ultimately lead to improved detection and management of glaucoma.

It is hypothesized that subjects with keratoconus have an abnormal biomechanical response of the lamina cribrosa in response to IOP modulation.


Condition or disease Intervention/treatment Phase
Keratoconus Glaucoma Device: Ophthalmodynamometer Device: Goldmann applanation tonometer Device: Pentacam Device: ORA Device: Optical Coherence Tomography (OCT) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus
Actual Study Start Date : November 15, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Subjects With Keratoconus Device: Ophthalmodynamometer
The ODM (Baillart ophthlmodynamometer) is a disc attached to a piston that induces a controlled force on a fixed area. The device will be used to apply a pressure within the range of 10 mmHg - 50 mmHg 4 times to each eye. Each increase of pressure will last approximately 30 seconds. The device is FDA approved and will be used as routinely used in clinical practice

Device: Goldmann applanation tonometer
The Goldmann applanation tonometer (Haag-Streit, Basel, Switzerland) measures the IOP after the eye is numbed with a drop of anesthetic (proparacaine), which is approved by the FDA. Proparacaine is part of routine patient care using a tonometer regardless of participation in this study. The instrument's tip lightly touches the surface of the cornea and the IOP is measured. The device is FDA approved is routinely used in clinical practice.

Device: Pentacam
This device maps the cornea and provides pachymetry, topography and corneal aberration maps. The device is FDA approved and routinely used in clinical practice.

Device: ORA
ORA is an air puff tonometer that applies controlled force to flattens the cornea and provides the corneal hysteresis and corneal resistance factor. The device is FDA approved and routinely used in clinical practice.

Device: Optical Coherence Tomography (OCT)
OCT is a non-contact,real-time, high resolution, and reproducible imaging modality that provides in-vivo optical cross-sectional scanning of the retina, the ONH and of the anterior segment structures including the cornea. Clinical staff will perform subject testing, not research coordinators. Information about these non-FDA approved OCTs and the multi-modal adaptive optics system can be found in appendices A, B, C, and D. With all devices, the participant sits in a slit lamp like frame. A low power laser light is projected toward the back of their eyes while the subject fixates on a target. None of the systems produce harmful radioactive radiation.
Active Comparator: Subjects with Glaucoma Device: Ophthalmodynamometer
The ODM (Baillart ophthlmodynamometer) is a disc attached to a piston that induces a controlled force on a fixed area. The device will be used to apply a pressure within the range of 10 mmHg - 50 mmHg 4 times to each eye. Each increase of pressure will last approximately 30 seconds. The device is FDA approved and will be used as routinely used in clinical practice

Device: Goldmann applanation tonometer
The Goldmann applanation tonometer (Haag-Streit, Basel, Switzerland) measures the IOP after the eye is numbed with a drop of anesthetic (proparacaine), which is approved by the FDA. Proparacaine is part of routine patient care using a tonometer regardless of participation in this study. The instrument's tip lightly touches the surface of the cornea and the IOP is measured. The device is FDA approved is routinely used in clinical practice.

Device: Pentacam
This device maps the cornea and provides pachymetry, topography and corneal aberration maps. The device is FDA approved and routinely used in clinical practice.

Device: ORA
ORA is an air puff tonometer that applies controlled force to flattens the cornea and provides the corneal hysteresis and corneal resistance factor. The device is FDA approved and routinely used in clinical practice.

Device: Optical Coherence Tomography (OCT)
OCT is a non-contact,real-time, high resolution, and reproducible imaging modality that provides in-vivo optical cross-sectional scanning of the retina, the ONH and of the anterior segment structures including the cornea. Clinical staff will perform subject testing, not research coordinators. Information about these non-FDA approved OCTs and the multi-modal adaptive optics system can be found in appendices A, B, C, and D. With all devices, the participant sits in a slit lamp like frame. A low power laser light is projected toward the back of their eyes while the subject fixates on a target. None of the systems produce harmful radioactive radiation.


Outcome Measures
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Primary Outcome Measures :
  1. LC measurements measured in microns [ Time Frame: 1 Day ]
    These micron measurements will be obtained from in vivio OCT images

  2. Anterior laminar displacement measured in microns [ Time Frame: 1 Day ]
    These micron measurements will be obtained from in vivio OCT images


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Candidates must meet the following inclusion criteria in order to participate in the study.

  • Ability to provide informed consent and to understand the study procedures

Keratoconus:

  • Clinical diagnosis of keratoconus
  • Central thinning of the cornea
  • Abnormal posterior ectasia.

Glaucoma:

  • Glaucomatous ONH abnormality: rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.
  • Two consecutive abnormal SITA standard perimetry tests with GHT outside normal limits.

Exclusion Criteria:

Candidates that meet any of the exclusion criteria at baseline will be excluded from study participation.

  • Media opacity (e.g. lens, vitreous, cornea).
  • Strabismus, nystagmus or a condition that would prevent fixation.
  • Diabetes with evidence of retinopathy.
  • Previous intraocular surgery or ocular trauma (with the exception of laser procedures and subjects that have undergone uneventful cataract surgery more than 6 months from enrollment date).
  • Neurological and non-glaucomatous causes for visual field damage.
  • Any intraocular non-glaucomatous ocular disorders.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03560609


Contacts
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Contact: Zena Moore +1 929 455 5539 Zena.Moore@nyulangone.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Edward Pei    646-501-8741    edward.pei@nyumc.org   
Principal Investigator: Chaim Wollstein, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Chaim Wollstein NYU Langone Health
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03560609    
Other Study ID Numbers: 17-01360
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: May 10, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Deidentified data will be shared upon request.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Data is available upon reasonable request indefinitely
Access Criteria: Requests should be directed to Gadi.wollstein@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Keratoconus
Eye Diseases
Corneal Diseases