search
Back to results

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
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fuchs' Corneal Dystrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 18, 2014
Last Updated
August 20, 2015
Sponsor
Medical College of Wisconsin
search

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

Learn more about this trial

Combined Cataract Surgery and Planned Descemetorhexis

We'll reach out to this number within 24 hrs