Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The IOP Elevation Study is researching how increased pressure in the eye, known as intraocular pressure (IOP), may lead to vision loss in glaucoma. The study aims to better understand the changes in the eye that occur when IOP rises and how these changes can cause damage to important structures in the eye, particularly the optic nerve head (ONH) and the lamina cribrosa (LC). Scientists hope that by learning more about these processes, they can develop better treatments for glaucoma.
To participate in this study, you must be a healthy volunteer or have been identified as a glaucoma suspect or patient. Healthy volunteers should not have a family history of glaucoma and must have normal eye exams. Those with glaucoma suspects may have slightly elevated IOP or differences in eye structure but should still have normal vision tests. Participants can expect to undergo various eye examinations to assess their condition and help researchers gather important data. If you're interested, this study is currently recruiting participants of all genders aged between 65 and 87 years.
Gender
ALL
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.
About Nyu Langone Health
NYU Langone Health is a premier academic medical center located in New York City, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a leading sponsor of clinical trials, NYU Langone Health integrates cutting-edge scientific inquiry with patient-centered care, striving to develop new therapies and improve health outcomes across a wide range of medical conditions. The institution is dedicated to fostering collaboration among researchers, clinicians, and patients, ensuring rigorous adherence to ethical standards and regulatory guidelines in all clinical research initiatives. By leveraging its extensive resources and expertise, NYU Langone Health aims to contribute significantly to the advancement of medical knowledge and the enhancement of patient care.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
New York, New York, United States
Patients applied
Trial Officials
Gadi Wollstein, MD
Principal Investigator
NYU Langone Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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