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CompletedNCT02206594Updated Aug 21, 2015

Combined Cataract Surgery and Planned Descemetorhexis

An interventional study of Descemetorhexis in Fuchs' Corneal Dystrophy and Cataract, sponsored by Medical College of Wisconsin. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-21.

Sponsored by Medical College of Wisconsin · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
2
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Fuchs' Corneal Dystrophy
  • Cataract
03

In context

Cataract

1,701 studies on the registry are indexed under Cataract; 230 are open to participants now.

This study's enrollment of 2 is below the median of 80 across 1,155 interventional studies indexed under Cataract.

Browse Cataract studies →

Lead sponsor

Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.

Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2 participants (actual)

Study arms

  • Experimental
    Descemetorhexis

    Procedure: Descemetorhexis

Interventions

  • ProcedureDescemetorhexis
06

What researchers measure

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

07

Study locations

1 site
  • The Medical College of Wisconsin
    Milwaukee, Wisconsin 53226, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02206594
Lead sponsor
Medical College of Wisconsin
Responsible party
Steve Koenig (Steven B. Koenig, MD, Medical College of Wisconsin) — Principal investigator
First posted
Aug 1, 2014
Start date
Jan 2014
Primary completion
Aug 2015
Last update
Aug 21, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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Discussion

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