Combined Cataract Surgery and Planned Descemetorhexis

Cataract Clinical Trial

Official title:

Combined Cataract Surgery and Planned Descemetorhexis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02206594
• Other study ID #: MCW-EI-001
• Status: Completed
• Phase: N/A
• First received: April 18, 2014
• Last updated: August 20, 2015
• Start date: January 2014

Study information

• Verified date: July 2014
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cataract
• Fuchs' Corneal Dystrophy
• Fuchs' Endothelial Dystrophy

Intervention

Procedure:
• Descemetorhexis

Locations

Country	Name	City	State
United States	The Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Reconstitution of the endothelial cell layer as assessed by specular microscopy		Assessed up to 1 year following descemetorhexis	No
Primary	Corneal clarity as assessed by slit lamp photography		Assessed up to 1 year following descemetorhexis	No
Secondary	Resolution of edema as assessed by slit lamp photography		Assessed up to 1 year following descemetorhexis	No