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

Primary Purpose

Keratoconus, Glaucoma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Ophthalmodynamometer

Goldmann applanation tonometer

Pentacam

ORA

Optical Coherence Tomography (OCT)

About this trial

This is an interventional treatment trial for Keratoconus

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

New York University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Subjects With Keratoconus

Subjects with Glaucoma

Arm Description

Outcomes

Primary Outcome Measures

LC measurements measured in microns

These micron measurements will be obtained from in vivio OCT images

Anterior laminar displacement measured in microns

These micron measurements will be obtained from in vivio OCT images

Secondary Outcome Measures

Full Information

NCT ID

NCT03560609

First Posted

June 6, 2018

Last Updated

October 3, 2023

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT03560609

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 15, 2018 (Actual)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratoconus, Glaucoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Subjects With Keratoconus

Arm Type

Active Comparator

Arm Title

Subjects with Glaucoma

Arm Type

Active Comparator

Intervention Type

Device

Intervention Name(s)

Ophthalmodynamometer

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Goldmann applanation tonometer

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Pentacam

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

ORA

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Optical Coherence Tomography (OCT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

LC measurements measured in microns

Description

These micron measurements will be obtained from in vivio OCT images

Time Frame

1 Day

Title

Anterior laminar displacement measured in microns

Description

These micron measurements will be obtained from in vivio OCT images

Time Frame

1 Day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jamika Singleton-Garvin

Phone

929-455-5522

Jamika.Singleton-Garvin@nyulangone.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chaim Wollstein

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jamika Singleton-Garvin

Phone

929-455-5522

Jamika.Singleton-Garvin@nyulangone.org

First Name & Middle Initial & Last Name & Degree

Chaim Wollstein, MD

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Deidentified data will be shared upon request.

IPD Sharing Time Frame

Data is available upon reasonable request indefinitely

IPD Sharing Access Criteria

Requests should be directed to Gadi.wollstein@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Learn more about this trial

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

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