Understanding how increased eye pressure affects glaucoma damage
Effects of Elevated Intraocular Pressure on the Lamina Cribrosa
NA · NYU Langone Health · NCT03400137
This study tests how a short increase in eye pressure affects the optic nerve in people with glaucoma to better understand the damage it causes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | NYU Langone Health (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT03400137 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the understanding of the mechanisms behind glaucomatous damage by examining the effects of elevated intraocular pressure (IOP) on the optic nerve head and lamina cribrosa in living subjects. Participants will undergo a brief increase in eye pressure, and the resulting changes will be assessed using optical coherence tomography imaging. The study will measure the deformation of the lamina cribrosa in response to IOP modulation, providing insights into the pathophysiology of glaucoma.
Who should consider this trial
Good fit: Ideal candidates include healthy volunteers, glaucoma suspects, and patients with diagnosed glaucoma who meet specific inclusion criteria.
Not a fit: Patients with media opacity, strabismus, or diabetes with retinopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of glaucoma, potentially reducing vision loss for patients.
How similar studies have performed: While studies on IOP modulation exist, this specific approach focusing on in-vivo mechanical responses is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Gadi Wollstein, MD — NYU Langone Health
- Study coordinator: Jamika Singleton-Garvin
- Email: Jamika.Singleton-Garvin@nyulangone.org
- Phone: +1 929 455 5539
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Intraocular Pressure