Status:
RECRUITING
IOP Elevation Study
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
National Eye Institute (NEI)
Conditions:
Intraocular Pressure
Eligibility:
All Genders
18-90 years
Phase:
NA
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 sti...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 7 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 8 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03400137
Start Date
March 7 2018
End Date
May 8 2024
Last Update
August 31 2023
Active Locations (1)
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1
NYU Langone Health
New York, New York, United States, 10016