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Completed

NCT Number: NCT02206594

Combined Cataract Surgery and Planned Descemetorhexis

A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of Fuchs' corneal dystrophy.

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Key information

Conditions

Fuchs' Corneal Dystrophy Cataract Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Eye Diseases Eye Diseases, Hereditary Fuchs' Endothelial Dystrophy Genetic Diseases, Inborn Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Who can participate

Healthy volunteers accepted: No

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

General Inclusion Criteria:

  • Patient >18 years old
  • Willing and able to provide informed consent

Ocular Inclusion Criteria (all ocular inclusion criteria apply only to the study eye):

  • Fuchs' corneal dystrophy diagnosed
  • Cataract present
  • Best corrected visual acuity ≤ 20/40
  • Candidate for current endothelial transplant procedure (DSAEK, DMEK)

General Exclusion Criteria:

  • <18 years old
  • Medically unstable patient
  • Monocular patient
  • Unwilling or unable to provide informed consent

Ocular Exclusion Criteria (all ocular exclusion criteria apply only to the study eye):

  • Corneal dystrophy other than Fuchs'
  • Central corneal scar or central opacity not related to Fuchs'
  • Severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy
  • History of prior vitreoretinal surgery
  • Advanced or unstable glaucoma
  • Known steroid responders with glaucoma

Treatment and study plan

Descemetorhexis

Procedure

Primary outcomes

  1. Corneal clarity as assessed by slit lamp photography

    Time frame: Assessed up to 1 year following descemetorhexis

Secondary outcomes

  1. Resolution of edema as assessed by slit lamp photography

    Time frame: Assessed up to 1 year following descemetorhexis

Other outcomes

  1. Reconstitution of the endothelial cell layer as assessed by specular microscopy

    Time frame: Assessed up to 1 year following descemetorhexis

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
First posted
Aug 1, 2014
Registry last updated
Aug 21, 2015

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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