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

NCT03560609 | Terminated Results FDA Device

• 2 other identifiers: 17-01360R01EY013178
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconus; Glaucoma

Outcome Measures

Primary Outcomes (8)

• Number of Patients With Tissue Deformation in ONH Region

  Determination of tissue deformation will be obtained from OCT images.

  1 Day

• Number of Patients With Tissue Deformation in Peripapillary Region

  Determination of tissue deformation will be obtained from OCT images.

  1 Day

• Change in Rim Area (ONH Region) Under Elevated Intraocular Pressure

  Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.

  1 Day

• Change in Rim Area (Peripapillary Region) Under Elevated Intraocular Pressure

  Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.

  1 Day

• Change in Cup Depth (ONH Region) Under Elevated Intraocular Pressure

  Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.

  1 Day

• Change in Cup Depth (Peripapillary Region) Under Elevated Intraocular Pressure

  Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.

  1 Day

• Change in Lamina Cibrosa Area (ONH Region) Under Elevated Intraocular Pressure

  Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.

  1 Day

• Change in Lamina Cibrosa Area (Peripapillary Region) Under Elevated Intraocular Pressure

  Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.

  1 Day

Study Arms (2)

Subjects With Keratoconus

ACTIVE COMPARATOR

Device: Ophthalmodynamometer; Device: Goldmann applanation tonometer; Device: Pentacam; Device: ORA; Device: Optical Coherence Tomography (OCT)

Subjects with Glaucoma

ACTIVE COMPARATOR

Device: Ophthalmodynamometer; Device: Goldmann applanation tonometer; Device: Pentacam; Device: ORA; Device: Optical Coherence Tomography (OCT)

Interventions

Ophthalmodynamometer DEVICE

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

Subjects With Keratoconus; Subjects with Glaucoma

Goldmann applanation tonometer DEVICE

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.

Subjects With Keratoconus; Subjects with Glaucoma

Pentacam DEVICE

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

Subjects With Keratoconus; Subjects with Glaucoma

ORA DEVICE

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.

Subjects With Keratoconus; Subjects with Glaucoma

Optical Coherence Tomography (OCT) DEVICE

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.

Subjects With Keratoconus; Subjects with Glaucoma

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead
• National Eye Institute (NEI): collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Keratoconus; Glaucoma

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases; Ocular Hypertension

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Results Point of Contact

• Title: Jamika Singleton-Garvin
• Organization: NYU Langone Health

jamika.singleton-garvin@nyulangone.org

(212) 263-2573

Study Officials

• Chaim Wollstein

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 18, 2018
• Study Start: November 15, 2018
• Primary Completion: February 10, 2023
• Study Completion: January 19, 2024
• Last Updated: January 29, 2025
• Results First Posted: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)