MIGS VS SLT Comparison in Glaucoma Patients

Phase 3

• Conditions: Glaucoma
• Interventions: Device: MIGS Hydrus Ivantis; Procedure: 360 degrees SLT

• 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.

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2014-04
• Status Verified: 2015-07
• Study First Submitted: 2015-07-19
• Study First Submitted QC: 2015-07-29
• Last Update Submitted: 2015-07-29
• Study First Posted: 2015-07-30
• Last Update Posted: 2015-07-30
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MIGS Hydrus Ivantis	MIGS Hydrus Ivantis	opening the anterior chamber (2mm.) injecting visco-material, injecting the Hydrus stent in the Schlemm's canal under gonioscopic control
SLT	360 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

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

Trial Locations

Locations (1)

Ophthalmology Institute, University of Turin; 🇮🇹 Turin, Italy