Outcomes of Descemet Membrane Endothelial Keratoplasty

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: 15-005241
    Sponsor Protocol Number: 15-005241

About this study

The goal of this study is to determine optical and visual function through 5 years after Descemet membrane endothelial keratoplasty (DMEK). The study will also determine graft health (corneal endothelial cell loss) and survival through 5 years after DMEK, and factors associated with these outcomes, as well as assess the relationship between optical and anatomical corneal rehabilitation after DMEK.

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

  • Patient age 21 years or older; either sex.
  • Corneal endothelial disease: Presence of corneal endothelial dysfunction requiring keratoplasty, including pseudophakic corneal edema and Fuchs endothelial dystrophy.
  • Lenticular status: Pseudophakic with posterior chamber intraocular lens or phakic with or without cataract requiring extraction.

Exclusion Criteria

  • Uncontrolled glaucoma or prior filtering surgery (tube shunt or trabeculectomy).
  • Uncontrolled uveitis.
  • High graft failure risk including herpetic keratouveitis or any condition with two or more quadrants of stromal neovascularization.
  • Presence of anterior chamber intraocular lens.
  • Pregnancy
  • Those unlikely to complete the study due to plans to move, preference to follow-up with local provider, international patients, 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

Sanjay Patel, M.D.

Open for enrollment

Contact information:

Emily Treichel

(507)284-8558

Treichel.Emily@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20306505

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