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Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device

NCT02554214 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2015-09-18

No results posted yet for this study

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

Interventions

DEVICE

Glafkos drainage device

Sponsors & Collaborators

  • Rheon Medical SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2017-09-30

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02554214 on ClinicalTrials.gov