NCT02512133

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 19, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 30, 2015

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 30, 2015

Status Verified

July 1, 2015

Enrollment Period

2.2 years

First QC Date

July 19, 2015

Last Update Submit

July 29, 2015

Conditions

Glaucoma

Keywords

MIGSSLT

Outcome Measures

Primary Outcomes (1)

  • change in the intraocular pressure compared to baseline

    measurement with GAT in mm Hg

    up to 12 months

Secondary Outcomes (1)

  • change in the number of glaucoma medications compared to baseline

    up to 12 months

Other Outcomes (2)

  • change of visual acuity compared to baseline

    6 months and 1 year post-intervention

  • change of visual field compared to baseline

    1 year post-intervention

Study Arms (2)

MIGS Hydrus Ivantis

EXPERIMENTAL

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

Device: MIGS Hydrus Ivantis

SLT

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

Procedure: 360 degrees SLT

Interventions

MIGS Hydrus IvantisDEVICE

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

MIGS Hydrus Ivantis
360 degrees SLTPROCEDURE

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

SLT

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary open angle glaucoma diagnosis, intolerant or unresponsive to therapy or not controlled with therapy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ophthalmology Institute, University of Turin

Turin, 10138, Italy

Location

Related Publications (1)

  • 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.

    PMID: 35943114DERIVED

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Antonio Fea, MD

    Clinica Oculistica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Aggregate Professor

Study Record Dates

First Submitted

July 19, 2015

First Posted

July 30, 2015

Study Start

February 1, 2012

Primary Completion

April 1, 2014

Study Completion

July 1, 2017

Last Updated

July 30, 2015

Record last verified: 2015-07

Locations

IT(1)