Combined Cataract Surgery and Planned Descemetorhexis
Primary Purpose
Fuchs' Corneal Dystrophy, Cataract
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Descemetorhexis
Sponsored by
About this trial
This is an interventional treatment trial for Fuchs' Corneal Dystrophy
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
Sites / Locations
- The Medical College of Wisconsin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Descemetorhexis
Arm Description
Outcomes
Primary Outcome Measures
Corneal clarity as assessed by slit lamp photography
Secondary Outcome Measures
Resolution of edema as assessed by slit lamp photography
Full Information
NCT ID
NCT02206594
First Posted
April 18, 2014
Last Updated
August 20, 2015
Sponsor
Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT02206594
Brief Title
Combined Cataract Surgery and Planned Descemetorhexis
Official Title
Combined Cataract Surgery and Planned Descemetorhexis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A pilot study designed to assess the feasibility of planned descemetorhexis for the treatment of Fuchs' corneal dystrophy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Corneal Dystrophy, Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Descemetorhexis
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Descemetorhexis
Primary Outcome Measure Information:
Title
Corneal clarity as assessed by slit lamp photography
Time Frame
Assessed up to 1 year following descemetorhexis
Secondary Outcome Measure Information:
Title
Resolution of edema as assessed by slit lamp photography
Time Frame
Assessed up to 1 year following descemetorhexis
Other Pre-specified Outcome Measures:
Title
Reconstitution of the endothelial cell layer as assessed by specular microscopy
Time Frame
Assessed up to 1 year following descemetorhexis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
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
Facility Information:
Facility Name
The Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
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Combined Cataract Surgery and Planned Descemetorhexis
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