Glaucoma
Conditions
Keywords
MIGS, SLT
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.
Interventions
DEVICEMIGS Hydrus Ivantis
implant of the micro stent in the nasal Schlemm's canal
PROCEDURE360 degrees SLT
Laser Solutis SLT laser (Quantel Medical, Clermont-Ferrand, France): this frequency-doubled, Q-switched Nd:YAG laser emits light at a wavelength of 532 nm, with a pulse duration of 4 ns, a spot size of 400 µm and pulse energy ranging from 0.2 to 2 mJ
Sponsors
University of Siena
University of Turin, Italy
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* primary open angle glaucoma diagnosis, intolerant or unresponsive to therapy or not controlled with therapy
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in the intraocular pressure compared to baseline | up to 12 months | measurement with GAT in mm Hg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in the number of glaucoma medications compared to baseline | up to 12 months | accountability of IOP lowering medications used by the patient |
Other
| Measure | Time frame | Description |
|---|---|---|
| change of visual acuity compared to baseline | 6 months and 1 year post-intervention | ETDRS visual acuity scale |
| change of visual field compared to baseline | 1 year post-intervention | MD and PSD |
Countries
Italy
Outcome results
None listed