Understanding how increased eye pressure affects glaucoma damage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.