Status:
COMPLETED
Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.
Lead Sponsor:
Ivantis, Inc.
Conditions:
Primary Open Angle Glaucoma
Glaucoma, Open Angle, Pseudo-exfoliative
Eligibility:
All Genders
21-80 years
Phase:
NA
Brief Summary
The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.
Detailed Description
This is a post-market, prospective, single-masked, randomized, controlled, multicenter clinical trial comparing Cataract Extraction (CE) surgery + Hydrus Implant vs CE surgery alone for the reduction ...
Eligibility Criteria
Inclusion
- Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma.
- Operable, age-related cataract eligible for phacoemulsification.
Exclusion
- Closed Angle and narrow angle forms of Glaucoma.
- Other Secondary Glaucoma, (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venous pressure; congenital or developmental glaucoma.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01818115
Start Date
January 1 2011
End Date
November 1 2015
Last Update
February 4 2019
Active Locations (7)
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1
See Central Contact
Frankfurt, Germany
2
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Mainz, Germany
3
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Parma, Italy
4
See Central Contact
Torino, Italy