NCT02554214

Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Rheon Medical SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This will be a prospective, descriptive, mono-center, non-comparative study. A sample of 30 patients who satisfy entry criteria is estimated to be appropriate to provide safety and performance data for this study. The objectives of the study are to verify the performance and safety of the Glafkos adjustable glaucoma drainage device system. Performance will be measured assessing the possibility to adjust the intra-ocular pressure post-operatively. Safety will be measured by the incidence and severity of adverse events. The Glafkos device will be implanted in combination with a seton tube. The implant is placed under a scleral flap, in a manner analogous to the ex-Press device (Alcon). The distal end of the draining tube is linked to a seton draining tube, which is linked to a plate placed under the extraocular muscles, creating a filtering space at the orbit (filtering bleb).

Conditions

• Glaucoma

Interventions

Type	Name	Description
DEVICE	Glafkos drainage device

Timeline

• Start date: 2015-09-01
• Primary completion: 2017-09-01
• First posted: 2015-09-18
• Last updated: 2015-09-18

Locations

1 site across 1 country: Switzerland