MIGS VS SLT Comparison in Glaucoma Patients

University of Turin

Status and phase: Unknown; Phase 3

Conditions: Glaucoma

Treatments: Device: MIGS Hydrus Ivantis; Procedure: 360 degrees SLT

Study type: Interventional

Funder types: Other

Identifiers

NCT02512133

1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

MIGS Hydrus Ivantis

Experimental group

Description:

opening the anterior chamber (2mm.) injecting visco-material, injecting the Hydrus stent in the Schlemm's canal under gonioscopic control

Treatment:

Device: MIGS Hydrus Ivantis

SLT

Experimental group

Description:

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

Treatment:

Procedure: 360 degrees SLT