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OpenTrials
Completed

NCT Number: NCT00800111

Study of Endothelial Keratoplasty Outcomes

Endothelial keratoplasty is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. This technique offers many advantages compared with traditional full-thickness cornea transplants. Patients experience minimal change in glasses prescription and usually recover useful vision within weeks. Visual fluctuations are minimal during the healing process. The patient's cornea remains structurally intact and is more resistant to injury.

Endothelial keratoplasty is undergoing rapid and widespread adoption. Between 2005 and 2007, the number of corneas placed by US eye banks for endothelial keratoplasty increased ten-fold (2007 Eye Bank Association of America Annual Report). However, the procedure is less than 10 years old, and little is known about long term outcomes. Endothelial keratoplasty candidates at our center are invited to participate in an open enrollment, prospective study of the long-term outcomes of this procedure.

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Key information

Conditions

Fuchs' Endothelial Corneal Dystrophy Bullous Keratopathy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn Iridocorneal Endothelial Syndrome Iris Diseases Posterior Polymorphous Dystrophy Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female aged 18 or older
  • Scheduled to undergo endothelial keratoplasty
  • Able to provide written informed consent.

Exclusion criteria

  • Age less than 18 years

Treatment and study plan

Endothelial keratoplasty

Procedure

Endothelial keratoplasty is surgical replacement of the corneal endothelial cell layer (the cell layer lining the inner surface of the cornea).

Other names: Descemet stripping endothelial keratoplasty, Descemet stripping automated endothelial keratoplasty, Descemet membrane endothelial keratoplasty, DSEK, DSAEK, DMEK

Primary outcomes

  1. Visual acuity

    Time frame: 1, 3, 6, and 12 months and annually

Secondary outcomes

  1. Endothelial cell density

    Time frame: 6 months, 12 months and annually

  2. Intraocular pressure

    Time frame: 1, 3, 6, 12 months and annually

  3. Manifest refraction

    Time frame: 1, 3, 6, 12 months and annually

  4. corneal pachymetry

    Time frame: 1, 3, 6, 12 months and annually

Sponsors and collaborators

Lead sponsor

Cornea Research Foundation of America

Other

Registry information

Official study title

Open-enrollment, Prospective Study of Endothelial Keratoplasty Outcomes

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
Dec 1, 2008
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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