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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ODM 5-group |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ODM 5 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual acuity (both eyes) | Measurement of uncorrected and best corrected visual acuity (both eyes) | Day 56 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with a Fuchs endothelial dystrophy-induced corneal edema and an ODM 5 therapy recommendation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Düsseldorf, Augenklinik | Düsseldorf | 40225 | Germany | |||
| Praxis Dr. Thomas Kaercher |
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| ID | Term |
|---|---|
| D005642 | Fuchs' Endothelial Dystrophy |
| D015715 | Corneal Edema |
| D004487 | Edema |
| ID | Term |
|---|---|
| D003317 | Corneal Dystrophies, Hereditary |
| D003316 | Corneal Diseases |
| D005128 | Eye Diseases |
| D015785 | Eye Diseases, Hereditary |
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|
| 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):
| 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 |
| Heidelberg |
| 69121 |
| Germany |
| Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik | Magdeburg | 39120 | Germany |
| Augenklinik der Ludwig-Maximilians-Universität (LMU), Klinikum der Universität München | München | 80336 | Germany |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |