Keratoconus, Glaucoma
Conditions
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.
Interventions
DEVICEOphthalmodynamometer
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
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.
DEVICEPentacam
This device maps the cornea and provides pachymetry, topography and corneal aberration maps. The device is FDA approved and routinely used in clinical practice.
DEVICEORA
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.
DEVICEOptical 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.
Sponsors
National Eye Institute (NEI)
NYU Langone Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Tissue Deformation in ONH Region | 1 Day | Determination of tissue deformation will be obtained from OCT images. |
| Number of Patients With Tissue Deformation in Peripapillary Region | 1 Day | Determination of tissue deformation will be obtained from OCT images. |
| Change in Rim Area (ONH Region) Under Elevated Intraocular Pressure | 1 Day | Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure. |
| Change in Rim Area (Peripapillary Region) Under Elevated Intraocular Pressure | 1 Day | Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure. |
| Change in Cup Depth (ONH Region) Under Elevated Intraocular Pressure | 1 Day | Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure. |
| Change in Cup Depth (Peripapillary Region) Under Elevated Intraocular Pressure | 1 Day | Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure. |
| Change in Lamina Cibrosa Area (ONH Region) Under Elevated Intraocular Pressure | 1 Day | Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure. |
| Change in Lamina Cibrosa Area (Peripapillary Region) Under Elevated Intraocular Pressure | 1 Day | Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Keratoconus Individuals with keratoconus. | 3 |
| Subjects With Glaucoma Individuals with glaucoma. | 0 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated due to departure of Principal Investigator from Sponsoring institution | 3 | 0 |
Baseline characteristics
| Characteristic | Subjects With Keratoconus | Total |
|---|---|---|
| Age, Continuous | 38.66 years STANDARD_DEVIATION 4.714 | 38.66 years STANDARD_DEVIATION 4.714 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment United States | 3 participants | 3 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
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.
Time frame: 1 Day
Population: 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.
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.
Time frame: 1 Day
Population: 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.
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.
Time frame: 1 Day
Population: 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.
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.
Time frame: 1 Day
Population: 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.
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.
Time frame: 1 Day
Population: 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.
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.
Time frame: 1 Day
Population: 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.
Primary
Number of Patients With Tissue Deformation in ONH Region
Determination of tissue deformation will be obtained from OCT images.
Time frame: 1 Day
Population: 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.
Primary
Number of Patients With Tissue Deformation in Peripapillary Region
Determination of tissue deformation will be obtained from OCT images.
Time frame: 1 Day
Population: 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.