IOP Elevation Study

• Sponsor: NYU Langone Health (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03400137
• Collaborator: National Eye Institute (NEI) (NIH)
• Enrollment: 150
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 80.9
• Patients Per Site Per Month: 1.9

Study Details

Study Description

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)	N/A

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 Design

• Study Type: Interventional
• Anticipated 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: Mar 7, 2018
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYU Langone Health	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health
• National Eye Institute (NEI)

Investigators

• Principal Investigator: Gadi Wollstein, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT03400137
• Other Study ID Numbers: 17-01027; R01EY013178
• First Posted: Jan 17, 2018
• Last Update Posted: Mar 25, 2022
• Last Verified: Mar 1, 2022

• 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

Study Results

No Results Posted as of Mar 25, 2022