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IOP Elevation Study for Glaucoma Understanding

This study aims to better understand how glaucoma, a condition that can lead to vision loss, develops. Researchers will briefly increase the pressure inside your eye (intraocular pressure or IOP) using an ophthalmodynanometer. They will then use special imaging (optical coherence tomography) to see how the optic nerve changes in response to this pressure. The study will look at these changes in healthy volunteers, people suspected of having glaucoma, and those already diagnosed with glaucoma. The goal is to learn more about how increased eye pressure affects the optic nerve, which could help in developing better treatments for glaucoma. This study is currently recruiting up to 150 participants aged 18 to 90.

Study design
This interventional study plans to enroll 150 participants. It will involve increasing intraocular pressure using an ophthalmodynanometer.
What's involved
You would have your intraocular pressure briefly increased using an ophthalmodynanometer. Imaging of your eye would be taken during this time.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, which assess the deformation of the lamina cribrosa, are measured at 10 minutes.

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NCT03400137

IOP Elevation Study

Recruiting
NAAges 18–90InterventionalBasic science
NYU Langone Health
~150 participants
Updated 2023-08-31 on ClinicalTrials.gov
What's tested:Increasing of intraocular pressure (IC)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of the deformation of the lamina cribrosa in healthy eye in response to increasing intraocular pressure.
Measured over 10 Minutes
+2 more outcomes measured

Conditions

Intraocular Pressure

Explore related trials

Glaucoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Gadi Wollstein, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

Who to contact

Jamika Singleton-Garvin
[email protected]
+1 929 455 5539
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

No family history (first degree relative) of glaucoma.
No history of IOP \>22 mmHg.
Normal appearing optic discs and RNFL on dilated fundus examination.
Normal Swedish interactive thresholding algorithm (SITA) standard perimetry tests as defined by glaucoma hemifield test (GHT) within normal limits.
Normal visual field as defined above.
Either IOP between 25 to 30 mmHg with central corneal thickness \< 550µm, or a difference ≥ 0.2 in cup to disc ratio between eyes.
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

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.

What this trial measures

  • Assessment of the deformation of the lamina cribrosa in healthy eye in response to increasing intraocular pressure.10 Minutes

    OCT scanning will be obtained at baseline and with increased IOP. The IOP elevation will last no longer than two minutes, during which scans will be acquired by the imaging device.

  • Assessment of the deformation of the lamina cribrosa in glaucoma suspect, in response to increasing intraocular pressure.10 Minutes

    OCT scanning will be obtained at baseline and with increased IOP. The IOP elevation will last no longer than two minutes, during which scans will be acquired by the imaging device.

  • Assessment of the deformation of the lamina cribrosa in glaucomatous eyes in response to increasing intraocular pressure.10 Minutes

    OCT scanning will be obtained at baseline and with increased IOP. The IOP elevation will last no longer than two minutes, during which scans will be acquired by the imaging device.