NCT03400137 · NYU Langone Health
IOP Elevation Study
What this study is about
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.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Increasing of intraocular pressure (IC)
intraocular pressure will be increased using an ophthalmodynanometer
Primary outcome measures
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.
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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- New York, New York
Collaborators
National Eye Institute (NEI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 31, 2023 · Source of record for eligibility and locations