KeratoconusNCT03560609
Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus
A study testing Ophthalmodynamometer, Goldmann applanation tonometer and Pentacam in people with Keratoconus and Glaucoma, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Keratoconus, Glaucoma
- What is being tested?
- Ophthalmodynamometer, Goldmann applanation tonometer and Pentacam
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 19 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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
- Being tested
- Ophthalmodynamometer, Goldmann applanation tonometer, Pentacam, ORA, Optical Coherence Tomography (OCT)
- Medical subject headings
- Keratoconus, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OphthalmodynamometerDevice
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
Goldmann applanation tonometerDevice
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.
PentacamDevice
This device maps the cornea and provides pachymetry, topography and corneal aberration maps. The device is FDA approved and routinely used in clinical practice.
ORADevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Subjects With Keratoconus | Active comparator | Not described Receives: Device: Ophthalmodynamometer; Device: Goldmann applanation tonometer; Device: Pentacam; Device: ORA; Device: Optical Coherence Tomography (OCT) |
| Subjects with Glaucoma | Active comparator | Not described Receives: Device: Ophthalmodynamometer; Device: Goldmann applanation tonometer; Device: Pentacam; Device: ORA; Device: Optical Coherence Tomography (OCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Tissue Deformation in ONH Region
Determination of tissue deformation will be obtained from OCT images.
Measured: 1 Day
Number of Patients With Tissue Deformation in Peripapillary Region
Determination of tissue deformation will be obtained from OCT images.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study start15 Nov 2018
- Primary completion10 Feb 2023
- Study completion19 Jan 2024
Why it stopped: This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for KeratoconusStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Sponsor
- Investigators
- Chaim Wollstein, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03560609
- Sponsor's protocol ID
- 17-01360
- Other IDs
- R01EY013178
- Status last verified
- Jan 2025
- First submitted
- 6 Jun 2018
- Last updated
- 29 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Deidentified data will be shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optic Nerve Head Structural Response to IOP Elevation in Patients With Keratoconus
- ClinicalTrials.gov ID
- NCT03560609
- Acronym / sponsor ID
- 17-01360
- Conditions
- Keratoconus, Glaucoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated due to the departure of the Principal Investigator from the Sponsoring institution.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 10 Feb 2023 (actual)
- Study completion
- 19 Jan 2024 (actual)
- First posted
- 18 Jun 2018 (actual)
- Results
- Posted 29 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Clinical diagnosis of keratoconus
- Central thinning of the cornea
- Abnormal posterior ectasia.
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OphthalmodynamometerThe 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 | Subjects With Keratoconus, Subjects with Glaucoma |
| Goldmann applanation tonometerThe 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 | Subjects With Keratoconus, Subjects with Glaucoma |
| PentacamThis device maps the cornea and provides pachymetry, topography and corneal aberration maps. The device is FDA approved and routinely used in clinical practice. | Device | Subjects With Keratoconus, Subjects with Glaucoma |
| ORAORA 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 | Subjects With Keratoconus, Subjects with Glaucoma |
| 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. | Device | Subjects With Keratoconus, Subjects with Glaucoma |
Primary outcome
Number of Patients With Tissue Deformation in ONH Region
Time frame: 1 Day
Determination of tissue deformation will be obtained from OCT images.
Number of Patients With Tissue Deformation in Peripapillary Region
Time frame: 1 Day
Determination of tissue deformation will be obtained from OCT images.
Change in Rim Area (ONH Region) Under Elevated Intraocular Pressure
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 1 Day
Obtained via OCT images - measure is from baseline to time of measurement during administration of elevated intraocular pressure.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Deidentified data will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chaim Wollstein principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ophthalmodynamometer, Goldmann applanation tonometer and Pentacam in people with Keratoconus and Glaucoma, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Tissue Deformation in ONH Region (time frame: 1 Day). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2025.