IOP Elevation Study
ConditionIntraocular Pressure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorNYU Langone Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Increasing of intraocular pressure (IC)
Diagnostic testintraocular pressure will be increased using an ophthalmodynanometer
Treatment groups
150 Participants
are divided into 3 treatment groupsGroup A: Healthy VolunteersActive comparator 1 intervention
Group B: Glaucoma suspectsActive comparator 1 intervention
Group C: GlaucomaActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 Minutes2
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.
Time frame
10 Minutes3
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.
Time frame
10 MinutesSponsors and contacts
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NYU Langone Health
Lead sponsor
National Eye Institute (NEI)
Collaborator
Source ClinicalTrials.gov