RECRUITING

IOP Elevation Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Effects of Elevated Intraocular Pressure on the Lamina Cribrosa

Quick Facts

Study Start:2018-03-07
Study Completion:2024-05-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03400137

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * No family history (first degree relative) of glaucoma.
  2. * No history of IOP \>22 mmHg.
  3. * Normal appearing optic discs and RNFL on dilated fundus examination.
  4. * Normal Swedish interactive thresholding algorithm (SITA) standard perimetry tests as defined by glaucoma hemifield test (GHT) within normal limits.
  5. * Normal visual field as defined above.
  6. * Either IOP between 25 to 30 mmHg with central corneal thickness \< 550µm, or a difference ≥ 0.2 in cup to disc ratio between eyes.
  7. * Glaucomatous ONH abnormality: rim thinning, notching, undermining (excavation) or diffuse or localized RNFL defects that are characteristic of glaucoma.
  8. * Two consecutive abnormal SITA standard perimetry tests with GHT outside normal limits.
  1. * Media opacity (e.g. lens, vitreous, cornea).
  2. * Strabismus, nystagmus or a condition that would prevent fixation.
  3. * Diabetes with evidence of retinopathy.
  4. * 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).
  5. * Neurological and non-glaucomatous causes for visual field damage.
  6. * Any intraocular non-glaucomatous ocular disorders.

Contacts and Locations

Study Contact

Jamika Singleton-Garvin
CONTACT
+1 929 455 5539
Jamika.Singleton-Garvin@nyulangone.org

Principal Investigator

Gadi Wollstein, MD
PRINCIPAL_INVESTIGATOR
NYU Langone Health

Study Locations (Sites)

NYU Langone Health
New York, New York, 10016
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Gadi Wollstein, MD, PRINCIPAL_INVESTIGATOR, NYU Langone Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-03-07
Study Completion Date2024-05-08

Study Record Updates

Study Start Date2018-03-07
Study Completion Date2024-05-08

Terms related to this study

Additional Relevant MeSH Terms

  • Intraocular Pressure