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Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Glaucoma Clinical Trial

Official title:
Clinical Study of the Safety and Performance of the Miami InnFocus Drainage Implant to Relieve Glaucoma Symptoms

Clinical Trial Summary

Assess the safety and performance of the Miami InnFocus Drainage Implant in patients suffering from glaucoma that is inadequately controlled on tolerated medical therapy with intraocular pressure greater than or equal to 18 mm Hg and less than or equal to 40 mm Hg.

Clinical Trial Description

Unicentric, non-randomized, single arm safety and performance study which will be conducted in accordance with the applicable parts of CFR 21 and Standard EN-ISO 14155 I & II: 2003 on clinical investigations with medical devices on human subjects and recommendations guiding physicians in biomedical research involving human subjects adopted by the 18th World Medical Assembly, Helsinki, Finland, 1964 and later revisions ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00772330
Study type Interventional
Source InnFocus Inc.
Contact
Status Completed
Phase N/A
Start date October 2007
Completion date January 2017
View Details
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