Combined Cataract Surgery and Planned Descemetorhexis

NCT ID: NCT02206594

Last Updated: 2015-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Brief Summary

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

Detailed Description

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Conditions

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Fuchs' Corneal Dystrophy Cataract

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Descemetorhexis

Group Type EXPERIMENTAL

Descemetorhexis

Intervention Type PROCEDURE

Interventions

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Descemetorhexis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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


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

Exclusion Criteria

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


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical College of Wisconsin

OTHER

Sponsor Role lead

Responsible Party

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Steve Koenig

Steven B. Koenig, MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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MCW-EI-001

Identifier Type: -

Identifier Source: org_study_id

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