Recruiting

Observational Study

Sponsor:

NYU Langone Health

Code:

NCT03400137

Conditions

Intraocular Pressure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Increasing of intraocular pressure (IC)

Study Details

Brief summary:

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.

Conditions

Intraocular Pressure

Study ID

NCT03400137

Start date

Mar 7, 2018

Status verified date

Aug, 2023

Completion date

May 8, 2024

Anticipated

Primary completion date

May 8, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

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.

Interventions

Increasing of intraocular pressure (IC)

intraocular pressure will be increased using an ophthalmodynanometer

Primary outcome measure

  • Assessment of the deformation of the lamina cribrosa in healthy eye in response to increasing intraocular pressure. [ Time Frame: 10 Minutes ]
  • Assessment of the deformation of the lamina cribrosa in glaucoma suspect, in response to increasing intraocular pressure. [ Time Frame: 10 Minutes ]
  • Assessment of the deformation of the lamina cribrosa in glaucomatous eyes in response to increasing intraocular pressure. [ Time Frame: 10 Minutes ]

Central Contacts and Locations

Central contacts

Jamika Singleton-Garvin

+1 929 455 5539Jamika.Singleton-Garvin@nyulangone.org

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Contacts

Jamika Singleton-Garvin

929-455-5522Jamika.Singleton-Garvin@nyulangone.org

Principal Investigator:

Gadi Wollstein, MD

More Information

Sponsor

NYU Langone Health

Last update posted

Aug 31, 2023

Last verified

Aug, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2023-08-31.