IOP Elevation Study

Intraocular Pressure Clinical Trial

Official title:

Effects of Elevated Intraocular Pressure on the Lamina Cribrosa

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03400137
• Other study ID #: 17-01027
• Secondary ID: R01EY013178
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: May 8, 2024

Study information

• Verified date: August 2023
• Source: NYU Langone Health
• Contact: Jamika Singleton-Garvin
• Phone: +1 929 455 5539
• Email: Jamika.Singleton-Garvin[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: May 8, 2024
• Est. primary completion date: May 8, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intraocular Pressure

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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