NCT02332109

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 29 (actual)
• Sponsor: TRB Chemedica AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fuchs' Endothelial Dystrophy
• Corneal Edema

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-05-01
• Completion: 2016-05-01
• First posted: 2015-01-06
• Last updated: 2016-06-07

Locations

4 sites across 1 country: Germany