IOP Elevation Study

Effects of Elevated Intraocular Pressure on the Lamina Cribrosa

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.

Study Overview

• Status: Recruiting
• Conditions: Intraocular Pressure
• Intervention / Treatment: Diagnostic test: Increasing of intraocular pressure (IC)

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
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jamika Singleton-Garvin; Phone Number: +1 929 455 5539; Email: Jamika.Singleton-Garvin@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Contact: Jamika Singleton-Garvin; Phone Number: 929-455-5522; Email: Jamika.Singleton-Garvin@nyulangone.org
      • Principal Investigator: Gadi Wollstein, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Eye Institute (NEI)
• Investigators: Principal Investigator: Gadi Wollstein, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Estimated): May 8, 2024
• Study Completion (Estimated): May 8, 2024

Study Registration Dates

• First Submitted: January 8, 2018
• First Submitted That Met QC Criteria: January 8, 2018
• First Posted (Actual): January 17, 2018

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 17-01027; R01EY013178 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No