Clinical Trial: ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy
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 Summary: 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.
Sponsor: TRB Chemedica AG
Current Primary Outcome: Visual acuity (both eyes) [ Time Frame: Day 56 ]
Original Primary Outcome: Corneal thickness [ Time Frame: Day 56 ]
Current Secondary Outcome:
- Corneal thickness [ Time Frame: Day 0, day 28 and day 56 ]Measurement of central corneal thickness (both eyes)
- Visual acuity (both eyes) [ Time Frame: Day 0 and day 28 ]Measurement of uncorrected and best corrected visual acuity (both eyes)
- Contrast perception (Measurement of contrast values (both eyes)) [ Time Frame: Day 0, day 28 and day 56 ]Measurement of contrast values (both eyes)
- Subjective ocular complaints and symptoms (11-point Likert scale) [ Time Frame: 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) [ Time Frame: Day 0, day 28 and day 56 ]Adverse events judged to be unexpected and (possibly) related to ODM 5 will be documented
Original Secondary Outcome:
- Corneal thickness [ Time Frame: Day 0 and day 14 ]Measurement of central corneal thickness (both eyes)
- Ametropia (Measurement of uncorrected and best corrected visual acuity (both eyes)) [ Time Frame: Day 0, day 14 and day 56 ]Measurement of uncorrected and best corrected visual acuity (both eyes)
- Contrast perception (Measurement of contrast values (both eyes)) [ Time Frame: Day 0, day 14 and day 56 ]Measurement of contrast values (both eyes)
- Subjective ocular complaints and symptoms (11-point Likert scale) [ Time Frame: Day 0, day 14 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) [ Time Frame: Day 0, day 14 and day 56 ]judged to be unexpected and (possibly) related to ODM 5 will be documented
Information By: TRB Chemedica AG
Dates:
Date Received: December 19, 2014
Date Started: September 2015
Date Completion:
Last Updated: June 6, 2016
Last Verified: June 2016