Overview

This trial is active, not recruiting.

Condition glaucoma
Treatments migs hydrus ivantis, 360 degrees slt
Phase phase 3
Sponsor University of Turin, Italy
Collaborator University of Siena
Start date February 2012
End date April 2014
Trial size 56 participants
Trial identifier NCT02512133, 1

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
opening the anterior chamber (2mm.) injecting visco-material, injecting the Hydrus stent in the Schlemm's canal under gonioscopic control
migs hydrus ivantis
implant of the micro stent in the nasal Schlemm's canal
(Experimental)
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
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 Outcomes

Measure
change in the intraocular pressure compared to baseline
time frame: up to 12 months

Secondary Outcomes

Measure
change in the number of glaucoma medications compared to baseline
time frame: up to 12 months

Eligibility Criteria

Male or female participants from 50 years up to 80 years old.

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

Additional Information

Official title MIGS VS SLT in Glaucoma Patients: Prospective Study
Principal investigator Antonio Fea, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by University of Turin, Italy.