Descemetorhexis only* for treatment of Fuchs endothelial dystrophy

Withdrawn

Conditions: Fuchs endothelial dystrophy / corneal disease
10015919
10015957

Registration Number: NL-OMON45640

Lead Sponsor: Melles Hoornvlieskliniek Rotterdam (MHR)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

- Fuchs endothelial dystrophy
- Indication for a corneal transplant
- Age * 18 years
- Agree to return for 1 day, 1 week, 1 month, 3 months 6 months, 9 months, and 12 months post-procedure follow-up visits

Exclusion Criteria

- Concomitant ocular disease and/or a contraindication for this type of treatment (e.g. inflammation of the eye, uveitis etc.)
- (Functional) oculus ultimus
- Severe diabetes
- Unable to sit on a chair in front of the laser for 30 minutes
- Unable to clearly understand the language used in the clinic (Dutch)
- Inability to give informed consent for any reason
- Pregnant or nursing

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- visual acuity, measured by the optometrist using a Snellen chart (standard<br /><br>procedure, also used for DMEK).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- endothelial cell density, as assessed by specular microscopy and confocal<br /><br>microscopy,<br /><br>- number of complications,<br /><br>- pachymetry of the cornea, measured using a Pentacam apparatus and an Anterior<br /><br>Segment Optical Coherence Tomography apparatus (AS-OCT),<br /><br>- corneal clarity; if the cornea fails to clear within the first 6 months after<br /><br>surgery, the patient will receive a re-operation (DMEK).<br /><br>- intraocular level of inflammation as measured with laser flare photometry</p><br>