MIGS VS SLT Comparison in Glaucoma Patients

Sponsor

University of Turin, Italy (Other)

Overall Status

Unknown status

CT.gov ID

NCT02512133

Collaborator

University of Siena (Other)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Glaucoma	Device: MIGS Hydrus Ivantis Procedure: 360 degrees SLT	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

56 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

MIGS VS SLT in Glaucoma Patients: Prospective Study

Study Start Date :

Feb 1, 2012

Actual Primary Completion Date :

Apr 1, 2014

Anticipated Study Completion Date :

Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MIGS Hydrus Ivantis opening the anterior chamber (2mm.) injecting visco-material, injecting the Hydrus stent in the Schlemm's canal under gonioscopic control	Device: MIGS Hydrus Ivantis implant of the micro stent in the nasal Schlemm's canal
Experimental: 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	Procedure: 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

Arm

Intervention/Treatment

Experimental: MIGS Hydrus Ivantis

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

Device: MIGS Hydrus Ivantis

implant of the micro stent in the nasal Schlemm's canal

Experimental: 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

Procedure: 360 degrees SLT

Outcome Measures

Primary Outcome Measures

change in the intraocular pressure compared to baseline [up to 12 months]
measurement with GAT in mm Hg

Secondary Outcome Measures

change in the number of glaucoma medications compared to baseline [up to 12 months]
accountability of IOP lowering medications used by the patient

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmology Institute, University of Turin	Turin		Italy	10138

Sponsors and Collaborators

University of Turin, Italy
University of Siena

Investigators

Principal Investigator: Antonio Fea, MD, Clinica Oculistica

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Antonio Fea, Aggregate Professor, University of Turin, Italy

ClinicalTrials.gov Identifier:

NCT02512133

Other Study ID Numbers:

First Posted:

Jul 30, 2015

Last Update Posted:

Jul 30, 2015

Last Verified:

Jul 1, 2015

Keywords provided by Antonio Fea, Aggregate Professor, University of Turin, Italy

MIGS

SLT

Additional relevant MeSH terms:

Glaucoma

Study Results

No Results Posted as of Jul 30, 2015