ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy

Study Overview
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Brief Summary
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Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment of corneal edema caused by Fuchs' endothelial dystrophy.

Detailed Description
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Patients with a Fuchs' endothelial dystrophy-induced corneal edema and an ODM 5 therapy recommendation prior to their inclusion will be observed in normal practice setting in this post-market clinical follow-up study. In this indication, the use of ODM 5 should extract the fluid excess in the cornea away by an osmotic effect, enabling the cornea to temporarily regain a normal state of hydration. As a consequence, the patient's visual acuity, contrast perception, corneal thickness and ocular complaints/symptoms should improve. The hyaluronan in ODM 5 helps to protect and heal the cornea in case of irritation and thus, enables the cornea to regain a normal state of hydration and participates in improving the quality of vision.

Official Title
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ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy

Conditions
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Fuchs' Endothelial Dystrophy, Corneal Edema

Intervention / Treatment
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* Device: ODM 5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of corneal oedema caused by Fuchs' endothelial dystrophy Existing ODM 5 recommendation prior to inclusion Exclusion Criteria: Contact lens wear Hypersensitivity to one of the ODM 5 components Appointment for eye surgery within 8 weeks after date of inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ODM 5-group<br> | Device: ODM 5<br>* ODM 5 is a CE-certified, preservative-free, hyperosmolar ophthalmological solution containing 5% sodium chloride and 0.15% sodium hyaluronate recommended for the reduction of corneal edema. The patient will use ODM 5 on a daily basis in accordance with the instructions for use and as recommended by the investigator over a period of 8 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity (both eyes) | Measurement of uncorrected and best corrected visual acuity (both eyes) | Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal thickness | Measurement of central corneal thickness (both eyes) | Day 0, day 28 and day 56 | 
| Visual acuity (both eyes) | Measurement of uncorrected and best corrected visual acuity (both eyes) | Day 0 and day 28 | 
| Contrast perception (Measurement of contrast values (both eyes)) | Measurement of contrast values (both eyes) | Day 0, day 28 and day 56 | 
| Subjective ocular complaints and symptoms (11-point Likert scale) | The following ocular complaints or symptoms will be evaluated on an 11-point Likert scale ranging from '0' (no complaints) to '10' (maximum complaints): glare sensitivity burning foreign body sensation halos pruritus blurred vision redness pain tingling stitching dryness watering eyes | Day 0, day 28 and day 56 | 
| Safety parameter (Adverse events) | Adverse events judged to be unexpected and (possibly) related to ODM 5 will be documented | Day 0, day 28 and day 56 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fuchs endothelial dystrophy, oedema, sodium chloride, hyaluronan, sodium hyaluronate