Actively Recruiting
Effects of Elevated Intraocular Pressure on the Lamina Cribrosa
Led by NYU Langone Health · Updated on 2023-08-31
150
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
N
NYU Langone Health
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the process that leads to damage in glaucoma, focusing on how increased intraocular pressure (IOP) affects vision loss. The study aims to better understand the role of the lamina cribrosa (LC) and the optic nerve head (ONH) in glaucoma development. This research is prospective and evaluates how the eye tissues respond mechanically to changes in IOP. In this study, the pressure inside the eye will be briefly raised using a device called an ophthalmodynamometer. Participants include healthy volunteers, glaucoma suspects, and those with glaucoma. Researchers will use optical coherence tomography imaging to measure changes in the shape and position of the optic nerve and lamina cribrosa during pressure elevation. These measurements quantify tissue deformation in microns. Participants will undergo eye imaging and pressure tests lasting about 10 minutes each to assess tissue response. The study monitors the deformation of the lamina cribrosa in healthy, suspect, and glaucomatous eyes. There is no randomization or blinding involved. The study involves a single visit with brief pressure elevation and imaging to collect data. Safety and eye health will be closely observed throughout the procedure.
CONDITIONS
Brief Title
IOP Elevation Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy volunteers with no family history of glaucoma in a first degree relative
- No history of intraocular pressure greater than 22 mmHg
- Normal appearing optic discs and retinal nerve fiber layer on eye exam
- Normal visual field test results as defined by glaucoma hemifield test within normal limits
- Glaucoma suspects with normal visual field and either IOP between 25 to 30 mmHg with central corneal thickness less than 550 microns, or a difference of 0.2 or more in cup to disc ratio between eyes
- Participants with glaucomatous optic nerve head abnormalities such as rim thinning, notching, excavation, or retinal nerve fiber layer defects
- Two consecutive abnormal visual field tests with glaucoma hemifield test outside normal limits
You will not qualify if you...
- Media opacity such as lens, vitreous, or cornea opacity
- Strabismus, nystagmus, or conditions preventing eye fixation
- Diabetes with evidence of retinopathy
- Previous intraocular surgery or eye trauma except laser procedures and cataract surgery more than 6 months before enrollment
- Neurological or non-glaucomatous causes of visual field damage
- Any intraocular non-glaucomatous eye disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 minutes
Participants undergo brief elevation of intraocular pressure using an ophthalmodynanometer while imaging the optic nerve to assess lamina cribrosa deformation.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
Research Team
J
Jamika Singleton-Garvin
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
3
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