MIGS VS SLT Comparison in Glaucoma Patients
- Conditions
- Glaucoma
- Registration Number
- NCT02512133
- Lead Sponsor
- University of Turin, Italy
- Brief 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).
- Detailed 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 56
- primary open angle glaucoma diagnosis, intolerant or unresponsive to therapy or not controlled with therapy
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method change in the intraocular pressure compared to baseline up to 12 months measurement with GAT in mm Hg
- Secondary Outcome Measures
Name Time Method change in the number of glaucoma medications compared to baseline up to 12 months accountability of IOP lowering medications used by the patient
Related Research Topics
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Trial Locations
- Locations (1)
Ophthalmology Institute, University of Turin
🇮🇹Turin, Italy
Ophthalmology Institute, University of Turin🇮🇹Turin, Italy