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.
Study Type
OBSERVATIONAL
Enrollment
29
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.
Universitätsklinikum Düsseldorf, Augenklinik
Düsseldorf, Germany
Praxis Dr. Thomas Kaercher
Heidelberg, Germany
Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
Magdeburg, Germany
Augenklinik der Ludwig-Maximilians-Universität (LMU), Klinikum der Universität München
München, Germany
Visual acuity (both eyes)
Measurement of uncorrected and best corrected visual acuity (both eyes)
Time frame: Day 56
Corneal thickness
Measurement of central corneal thickness (both eyes)
Time frame: Day 0, day 28 and day 56
Visual acuity (both eyes)
Measurement of uncorrected and best corrected visual acuity (both eyes)
Time frame: Day 0 and day 28
Contrast perception (Measurement of contrast values (both eyes))
Measurement of contrast values (both eyes)
Time frame: 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
Time frame: 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
Time frame: Day 0, day 28 and day 56
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.