ODM 5 in the Treatment of Corneal Edematous Fuchs' Endothelial Dystrophy

Completed

• Conditions: Fuchs' Endothelial Dystrophy; Corneal Edema
• Interventions: Device: ODM 5

• Registration Number: NCT02332109
• Lead Sponsor: TRB Chemedica AG

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 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 Timeline

• Study First Submitted: 2014-12-19
• Study First Submitted QC: 2015-01-02
• Study First Posted: 2015-01-06
• Study Start: 2015-09
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-06
• Last Update Posted: 2016-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ODM 5-group	ODM 5	-

Primary Outcome Measures

Name	Time	Method
Visual acuity (both eyes)	Day 56	Measurement of uncorrected and best corrected visual acuity (both eyes)

Secondary Outcome Measures

Name	Time	Method
Visual acuity (both eyes)	Day 0 and day 28	Measurement of uncorrected and best corrected visual acuity (both eyes)
Corneal thickness	Day 0, day 28 and day 56	Measurement of central corneal thickness (both eyes)
Contrast perception (Measurement of contrast values (both eyes))	Day 0, day 28 and day 56	Measurement of contrast values (both 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
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

Trial Locations

Locations (4)

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