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IOP Elevation Study

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ClinicalTrials.gov Identifier: NCT03400137
Recruitment Status : Recruiting
First Posted : January 17, 2018
Last Update Posted : April 5, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
New York University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Intraocular Pressure Diagnostic Test: Increasing of intraocular pressure (IC) Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Effects of Elevated Intraocular Pressure on the Lamina Cribrosa
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: Healthy Volunteers
No family history (first degree relative) of glaucoma.
Diagnostic Test: Increasing of intraocular pressure (IC)
intraocular pressure will be increased using an ophthalmodynanometer

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.
Diagnostic Test: Increasing of intraocular pressure (IC)
intraocular pressure will be increased using an ophthalmodynanometer

Active Comparator: Glaucoma
Rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.
Diagnostic Test: Increasing of intraocular pressure (IC)
intraocular pressure will be increased using an ophthalmodynanometer




Primary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03400137


Contacts
Contact: Katie Lucy 646 501 8741 katy.lucy@nyumc.org

Locations
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Katie Lucy    646-501-8741    katie.lucy@nyumc.org   
Principal Investigator: Gadi Wollstein, MD         
Sponsors and Collaborators
New York University School of Medicine
National Eye Institute (NEI)
Investigators
Principal Investigator: Gadi Wollstein, MD New York University School of Medicine

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03400137     History of Changes
Other Study ID Numbers: 17-01027
R01EY013178 ( U.S. NIH Grant/Contract )
First Posted: January 17, 2018    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No