Association Between Endothelial Cell Density and Corneal Swelling in Post-Penetrating Keratoplasty Scleral Contact Lens Wear

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: 17-003496
    Sponsor Protocol Number: 17-003496

About this study

The purpose of this study is to model the relationship between corneal swelling and cell density and determine how this relationship differs by contact lens type.

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:

  1. Post-PK cornea at least 5 years after keratoplasty (rationale: ECD plateaus 5 years post-PK; including corneas that are in the phase of rapid cell loss prior to 5 years will confound the relationships we are studying)
  2. Primary or repeat keratoplasty
  3. May have had cataract extraction and IOL, but may not have history of recent cataract surgery (within 6 months)
  4. Known habitual contact lens parameters if a contact lens wearer

Exclusion Criteria:

  1. Active graft rejection
  2. Graft on the path to failure
  3. Presence of uncontrolled glaucoma (IOP>25 corrected for corneal thickness using OHTS nomogram; because high IOP causes further cell loss)
  4. Active ocular surface disease (infectious conjunctivitis, infectious keratitis, atopic keratoconjunctivitis)
  5. Any optical opacities or ocular disease that decreases best corrected visual acuity (examples: macular degeneration, posterior capsular opacity, corneal opacities on the visual axis)
  6. Indication for PK was pseudophakic or aphakic bullous keratopathy (because this influences graft failure and cell loss)

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Muriel Schornack, O.D.

Open for enrollment

Contact information:

Jane Sultze

(507)284-5833

Sultze.Jane@mayo.edu

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CLS-20339564

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