ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ODM 5-group
|
Device: ODM 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.
|
Outcome Measures
Primary Outcome Measures
- Visual acuity (both eyes) [Day 56]
Measurement of uncorrected and best corrected visual acuity (both eyes)
Secondary Outcome Measures
- 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
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Universitätsklinikum Düsseldorf, Augenklinik | Düsseldorf | Germany | 40225 | |
| 2 | Praxis Dr. Thomas Kaercher | Heidelberg | Germany | 69121 | |
| 3 | Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik | Magdeburg | Germany | 39120 | |
| 4 | Augenklinik der Ludwig-Maximilians-Universität (LMU), Klinikum der Universität München | München | Germany | 80336 |
Sponsors and Collaborators
- TRB Chemedica AG
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ODM5FDE-PMCF-DE-2015-01