Evaluate how Measurements of the Cornea Correlate to the Function of the Inside Lining (Endothelium) of the Cornea


  • Study type

  • 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.
  • Sponsor Protocol Number: 14-004342

About this study

In Fuchs endothelial dystrophy, the function of the inside lining (endothelium) of the cornea is not normal. Determining the function of that layer requires hours of testing and is not convenient in clinical practice. In this study, we will make simple measurements of the cornea and compare those to the function of the inside lining of the cornea with the hope that the simple measurements will predict function. This could allow us to determine the function of the inside lining of the cornea in routine clinical practice in a simple and informative test.

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:

Fuchs Dystrophy Inclusion Criteria:

  • Presence of central or paracentral corneal guttae.
  • Any age (expected range will be 40-90).
  • Any sex or race.

Normal subjects Inclusion Criteria:

  • Absence of central or paracentral corneal guttae.
  • Ages 51-90 (to match the predominant age of subjects with Fuchs dystrophy).
  • Any sex or race.

Exclusion criteria will apply to subjects in both groups: 

  • Corneal disease (except Fuchs dystrophy in the Fuchs dystrophy group).
  • Previous ocular surgery.
  • Use of topical medications (except artificial tears) or systemic medications known to affect the cornea.
  • Glaucoma or ocular hypertension.
  • Systemic diseases known to affect the cornea, e.g. diabetes.

Additional contact information

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Phone: 800-664-4542 (toll-free)

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