An observational study in Fuchs' Endothelial Dystrophy and Corneal Edema, sponsored by TRB Chemedica AG. Completed at 4 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-07.
Sponsored by TRB Chemedica AG · Observational
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.
92 studies on the registry are indexed under Fuchs' Endothelial Dystrophy; 28 are open to participants now.
This study's enrollment of 29 is below the median of 168 across 25 observational studies indexed under Fuchs' Endothelial Dystrophy.
Browse Fuchs' Endothelial Dystrophy studies →TRB Chemedica AG is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a Fuchs endothelial dystrophy-induced corneal edema and an ODM 5 therapy recommendation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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
The record gives a start of Sep 2015, a primary completion of May 2016 and a completion of May 2016. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.
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Fuchs' Endothelial Dystrophy →
TRB Chemedica AG