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NCT Number: NCT03400137

IOP Elevation Study

The purpose of this study is to improve understanding of the pathophysiologic process that leads to the development of glaucamotous damage. 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 LC is a site of primary damage during pathogenesis of the disease. This prospective study with determine the in-vivo mechanical response to IOP modulation at the level of the ONH and LC.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Location contact

Gadi Wollstein, MD

PRINCIPAL_INVESTIGATOR

Jamika Singleton-Garvin

CONTACT

[email protected]

929-455-5522

About this study

The present study will briefly increase the pressure in eyes of living subjects and examine the effect of elevated intraocular pressure on optic nerve topography and position during pressure elevation using optical coherence tomography imaging of the posterior eye. Outcome measures will include measurements in microns based on these images quantifying the deformation of the lamina cribrosa.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy volunteers

  • 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.

Glaucoma suspects

  • 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.

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

  • 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.

Treatment and study plan

Increasing of intraocular pressure (IC)

Diagnostic Test

intraocular pressure will be increased using an ophthalmodynanometer

Primary outcomes

  1. Assessment of the deformation of the lamina cribrosa in healthy eye in response to increasing intraocular pressure.

    Time frame: 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.

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

    Time frame: 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.

  3. Assessment of the deformation of the lamina cribrosa in glaucomatous eyes in response to increasing intraocular pressure.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jamika Singleton-Garvin

CONTACT

[email protected]

+1 929 455 5539

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Eye Institute (NEI)

Registry information

Official study title

Effects of Elevated Intraocular Pressure on the Lamina Cribrosa

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Jan 17, 2018
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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