A Study to Assess for Changes in Optic Nerve Structure and Function due to Changes in Cerebrospinal Fluid Pressure

Overview

  • Study type

    Observational
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • Site IRB
    • Rochester, Minnesota: 14-007526
    Sponsor Protocol Number: 14-007526

About this study

The purpose of this study is to assess for changes in the structure and function of the optic nerve caused by changes in cerebrospinal fluid pressure.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

 Inclusion Criteria

  • Either gender
  • Caucasian ethnoracial category
  • ≥ 18 years of age
  • Has open angles
  • Ability to cooperate for visual testing
  • Nonprescription and prescription topical ophthalmic products and systemic medications other than those mentioned in the exclusion criteria will be allowed during the study
  • Able to participate on site over the multi-visit study period

Exclusion Criteria

  • Has narrow angles with complete or partial closure
  • Chronic or recurrent inflammatory eye disease
  • Ocular trauma within the past 6 months
  • Ocular infection or ocular inflammation in the past 3 months
  • Clinically significant retinal disease
  • Corneal abnormalities interfering with Goldmann tonometry
  • Previous intraocular surgery, except uncomplicated cataract extraction
  • Recent changes to systemic medications
    • Must be on a stable regimen for at least 30 days prior to visit 1 regarding a chronic systemic medication that may affect IOP (i.e., sympathomimetic agents, beta-blockers, alpha-adrenergic agonists, alpha-adrenergic blockers, calcium channel blockers, angiotensin converting enzyme inhibitors, etc.)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Arthur Sit, M.D.

Open for enrollment

Contact information:

Jane Sultze

(507)284-5833

Sultze.Jane@mayo.edu

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CLS-20304177

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