| NCT ID | NCT03400137 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NYU Langone Health |
| Condition | Intraocular Pressure |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2018-03-07 |
| Primary Completion | 2024-05-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2018-03-07 with a primary completion date of 2024-05-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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.
Contact & Investigator
Gadi Wollstein, MD
PRINCIPAL INVESTIGATOR
NYU Langone Health
Frequently Asked Questions
Who can join the NCT03400137 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Intraocular Pressure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03400137 currently recruiting?
Yes, NCT03400137 is actively recruiting participants. Contact the research team at Jamika.Singleton-Garvin@nyulangone.org for enrollment information.
Where is the NCT03400137 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT03400137 clinical trial?
NCT03400137 is sponsored by NYU Langone Health. The principal investigator is Gadi Wollstein, MD at NYU Langone Health. The trial plans to enroll 150 participants.