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Clinical Trial Summary

To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary open angle glaucoma (POAG).


Clinical Trial Description

Eligible study patients diagnosed with POAG and not sufficiently controlled by, intolerant of, or non-compliant with their current IOP-lowering regimen. Patients with IOP>21 mm Hg upon at least two consecutive measurements. Study subjects with typical glaucomatous visual field (VF) loss on Octopus or Humphrey automated perimetry (Carl Zeiss Meditec, Dublin, CA) and glaucomatous alterations to the optic nerve head. Visual field classified as glaucomatous according to the European Glaucoma Society guidelines.

Exclusion criteria : eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids. ;


Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02512133
Study type Interventional
Source University of Turin, Italy
Contact
Status Active, not recruiting
Phase Phase 3
Start date February 2012
Completion date July 2017

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