Corneal Edema, Fuchs' Endothelial Dystrophy
Conditions
Keywords
Fuchs endothelial dystrophy, oedema, sodium chloride, hyaluronan, sodium hyaluronate
Brief summary
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
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.
Interventions
DEVICEODM 5
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.
Sponsors
TRB Chemedica AG
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual acuity (both eyes) | Day 56 | Measurement of uncorrected and best corrected visual acuity (both eyes) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal thickness | Day 0, day 28 and day 56 | Measurement of central corneal thickness (both eyes) |
| Visual acuity (both eyes) | Day 0 and day 28 | Measurement of uncorrected and best corrected visual acuity (both eyes) |
| Contrast perception (Measurement of contrast values (both eyes)) | Day 0, day 28 and day 56 | Measurement of contrast values (both eyes) |
| Subjective ocular complaints and symptoms (11-point Likert scale) | Day 0, day 28 and day 56 | 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 |
| Safety parameter (Adverse events) | Day 0, day 28 and day 56 | Adverse events judged to be unexpected and (possibly) related to ODM 5 will be documented |
Countries
Germany
Outcome results
None listed