Status:
COMPLETED
A Clinical Trial of Phacoemulsification Versus Phacoemulsification & the iStent Implantation in POAG Patients
Lead Sponsor:
University of Turin, Italy
Conditions:
Primary Open Angle Glaucoma and Cataracts
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This was a prospective, double-masked, 15-month clinical trial comparing efficacy of phacoemulsification alone to combined phacoemulsification and implantation of the iStent® trabecular micro-bypass s...
Detailed Description
This was a prospective, randomized open-label study of 36 patients with POAG scheduled to undergo phacoemulsification with intraocular lens implantation ("cataract surgery"). Patients were randomized ...
Eligibility Criteria
Inclusion
- a previous diagnosis of POAG
- an IOP of \> 18 mm Hg at three separate visits if on one medication, or subjects on at least two medications with uncontrolled IOP on three separate visits.
- all patients were deemed likely to follow surgeon instructions and were able to give informed consent.
Exclusion
- any glaucoma diagnosis other than POAG
- the presence of peripheral anterior synechiae (PAS)
- a cloudy cornea likely to inhibit gonioscopic view of the angle
- any previous ocular surgery
- history of trauma or ocular surface disease
- the presence of peripheral anterior synechiae (PAS)
- a cloudy cornea likely to inhibit gonioscopic view of the angle
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00847158
Start Date
December 1 2006
End Date
March 1 2008
Last Update
February 19 2009
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