NCT03400137

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 17, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 7, 2018

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2024

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

6.2 years

First QC Date

January 8, 2018

Last Update Submit

August 30, 2023

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (3)

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

    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.

    10 Minutes

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

    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.

    10 Minutes

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

    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.

    10 Minutes

Study Arms (3)

Healthy Volunteers

ACTIVE COMPARATOR

No family history (first degree relative) of glaucoma.

Diagnostic Test: Increasing of intraocular pressure (IC)

Glaucoma suspects

ACTIVE COMPARATOR

oEither IOP between 25 to 30 mmHg with central corneal thickness \< 550µm, or a difference ≥ 0.2 in cup to disc ratio between eyes.

Diagnostic Test: Increasing of intraocular pressure (IC)

Glaucoma

ACTIVE COMPARATOR

Rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.

Diagnostic Test: Increasing of intraocular pressure (IC)

Interventions

Increasing of intraocular pressure (IC)DIAGNOSTIC_TEST

intraocular pressure will be increased using an ophthalmodynanometer

GlaucomaGlaucoma suspectsHealthy Volunteers

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

Study Officials

  • Gadi Wollstein, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamika Singleton-Garvin

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2018

First Posted

January 17, 2018

Study Start

March 7, 2018

Primary Completion

May 8, 2024

Study Completion

May 8, 2024

Last Updated

August 31, 2023

Record last verified: 2023-08

Locations

US(1)