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IOP Elevation Study

NYU Langone Health · with National Eye Institute (NEI) · NCT03400137

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–90 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
150
US sites recruiting
1
Study start
March 7, 2018
Record last updated
August 31, 2023

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Increasing of intraocular pressure (IC)

Conditions: Intraocular Pressure

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • NYU Langone Health

    New York, NY 10016

    Site contact: Jamika Singleton-Garvin · 929-455-5522 · Jamika.Singleton-Garvin@nyulangone.org

Study contacts (from the official record)

  • Jamika Singleton-Garvin · +1 929 455 5539 · Jamika.Singleton-Garvin@nyulangone.org
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IOP Elevation Study (NCT03400137) | Bored Studies