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| ID | Type | Description | Link |
|---|---|---|---|
| R01EY013178 | U.S. NIH Grant/Contract | View source |
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This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution.
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| Name | Class |
|---|---|
| National Eye Institute (NEI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects With Keratoconus | Active Comparator |
| |
| Subjects with Glaucoma | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Candidates must meet the following inclusion criteria in order to participate in the study.
Keratoconus:
Glaucoma:
Exclusion Criteria:
Candidates that meet any of the exclusion criteria at baseline will be excluded from study participation.
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| Name | Affiliation | Role |
|---|---|---|
| Chaim Wollstein | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Deidentified data will be shared upon request.
Data is available upon reasonable request indefinitely
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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This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. 3 participants were enrolled in the study; none of these participants were assessed for outcome measures. No participants (n=0) were enrolled into the "Subjects with Glaucoma" arm.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects With Keratoconus | Individuals with keratoconus. |
| FG001 | Subjects With Glaucoma | Individuals with glaucoma. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. No participants (n=0) were enrolled into the "Subjects with Glaucoma" arm.
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| ID | Title | Description |
|---|---|---|
| BG000 | Subjects With Keratoconus | Individuals with keratoconus. |
| BG001 | Subjects With Glaucoma | Individuals with glaucoma. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Tissue Deformation in ONH Region | Determination of tissue deformation will be obtained from OCT images. | This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure. | Posted | 1 Day |
|
Baseline (Day of collection of baseline characteristic data - 1 day)
No participants (n=0) were enrolled into the "Subjects with Glaucoma" arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Subjects With Keratoconus | Individuals with keratoconus. | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamika Singleton-Garvin | NYU Langone Health | (212) 263-2573 | jamika.singleton-garvin@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 13, 2023 | Oct 31, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 22, 2020 | Oct 31, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D007640 | Keratoconus |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D009798 | Ocular Hypertension |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Number of Patients With Tissue Deformation in Peripapillary Region | Determination of tissue deformation will be obtained from OCT images. | This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure. | Posted | 1 Day |
|
|
| Primary | 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. | This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure. | Posted | 1 Day |
|
|
| Primary | 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. | This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure. | Posted | 1 Day |
|
|
| Primary | 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. | This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure. | Posted | 1 Day |
|
|
| Primary | 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. | This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure. | Posted | 1 Day |
|
|
| Primary | 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. | This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure. | Posted | 1 Day |
|
|
| Primary | 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. | This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution. N=3 participants were enrolled in the study in the "Subjects with Keratoconus" arm, N=0 participants were enrolled in the "Subjects with Glaucoma". N=0 participants were assessed for outcome measures prior to study closure. | Posted | 1 Day |
|
|
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Subjects With Glaucoma | Individuals with glaucoma. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |