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 ]

Measurement of uncorrected and best corrected visual acuity (both eyes)


Original Primary Outcome: Corneal thickness [ Time Frame: Day 56 ]

Measurement of central corneal thickness (both eyes)


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