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

TRB Chemedica

Status: Completed

Conditions: Corneal Edema; Fuchs' Endothelial Dystrophy

Treatments: Device: ODM 5

Study type: Observational

Funder types: Industry

Identifiers

NCT02332109

ODM5FDE-PMCF-DE-2015-01

Details and patient eligibility

About

Clinical observation to confirm the clinical safety and efficacy of ODM 5 in the treatment of corneal edema caused by Fuchs' endothelial dystrophy.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

29 participants in 1 patient group

ODM 5-group

Treatment:

Device: ODM 5