IOP Elevation Study

Part of paid clinical trials in New York, New York.

Sponsor
NYU Langone Health
Study ID
NCT03400137
Status
Recruiting
Apply to this trial

Conditions

  • Intraocular Pressure

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Increasing of intraocular pressure (IC) — DIAGNOSTIC_TEST
    intraocular pressure will be increased using an ophthalmodynanometer

Study Details

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.

Key Dates

Start date
Mar 7, 2018
Status verified
Aug 2023
Primary completion
May 8, 2024
Completion
May 8, 2024

Study Design

Enrollment
150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Healthy Volunteers
    No family history (first degree relative) of glaucoma.
  • Active Comparator: Glaucoma suspects
    oEither IOP between 25 to 30 mmHg with central corneal thickness \< 550µm, or a difference ≥ 0.2 in cup to disc ratio between eyes.
  • Active Comparator: Glaucoma
    Rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.

Primary Outcome Measure

Assessment of the deformation of the lamina cribrosa in healthy eye in response to increasing intraocular pressure. [ Time Frame: 10 Minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NYU Langone HealthNew YorkNew York10016
Jamika Singleton-Garvin
[email protected]
929-455-5522
Gadi Wollstein, MD (PRINCIPAL_INVESTIGATOR)

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By research site
NYU Langone Health· New York, NY

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