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MIGS VS SLT Comparison in Glaucoma Patients

Primary Purpose

Glaucoma

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

MIGS Hydrus Ivantis

360 degrees SLT

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring MIGS, SLT

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Ophthalmology Institute, University of Turin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

MIGS Hydrus Ivantis

SLT

Arm Description

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

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

Outcomes

Primary Outcome Measures

change in the intraocular pressure compared to baseline

measurement with GAT in mm Hg

Secondary Outcome Measures

change in the number of glaucoma medications compared to baseline

accountability of IOP lowering medications used by the patient

Full Information

NCT ID

NCT02512133

First Posted

July 19, 2015

Last Updated

July 29, 2015

Sponsor

University of Turin, Italy

Collaborators

University of Siena

1. Study Identification

Unique Protocol Identification Number

NCT02512133

Brief Title

MIGS VS SLT Comparison in Glaucoma Patients

Official Title

MIGS VS SLT in Glaucoma Patients: Prospective Study

Study Type

Interventional

2. Study Status

Record Verification Date

July 2015

Overall Recruitment Status

Unknown status

Study Start Date

February 2012 (undefined)

Primary Completion Date

April 2014 (Actual)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Turin, Italy

Collaborators

University of Siena

4. Oversight

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Glaucoma

Keywords

MIGS, SLT

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MIGS Hydrus Ivantis

Arm Type

Experimental

Arm Description

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

Arm Title

SLT

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

MIGS Hydrus Ivantis

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

360 degrees SLT

Intervention Description

Primary Outcome Measure Information:

Title

change in the intraocular pressure compared to baseline

Description

measurement with GAT in mm Hg

Time Frame

up to 12 months

Secondary Outcome Measure Information:

Title

change in the number of glaucoma medications compared to baseline

Description

accountability of IOP lowering medications used by the patient

Time Frame

up to 12 months

Other Pre-specified Outcome Measures:

Title

change of visual acuity compared to baseline

Description

ETDRS visual acuity scale

Time Frame

6 months and 1 year post-intervention

Title

change of visual field compared to baseline

Description

MD and PSD

Time Frame

1 year post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Antonio Fea, MD

Organizational Affiliation

Clinica Oculistica

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ophthalmology Institute, University of Turin

City

Turin

ZIP/Postal Code

10138

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

35943114

Citation

Rolim-de-Moura CR, Paranhos A Jr, Loutfi M, Burton D, Wormald R, Evans JR. Laser trabeculoplasty for open-angle glaucoma and ocular hypertension. Cochrane Database Syst Rev. 2022 Aug 9;8(8):CD003919. doi: 10.1002/14651858.CD003919.pub3.

Results Reference

derived

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MIGS VS SLT Comparison in Glaucoma Patients

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