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MIGS VS SLT Comparison in Glaucoma Patients

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ClinicalTrials.gov Identifier: NCT02512133
Recruitment Status : Unknown
Verified July 2015 by Antonio Fea, University of Turin, Italy.
Recruitment status was:  Active, not recruiting
First Posted : July 30, 2015
Last Update Posted : July 30, 2015
Sponsor:
Collaborator:
University of Siena
Information provided by (Responsible Party):
Antonio Fea, 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).

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.


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Study Type : Interventional  (Clinical Trial)
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 : February 2012
Actual Primary Completion Date : April 2014
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

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




Primary Outcome Measures :
  1. change in the intraocular pressure compared to baseline [ Time Frame: up to 12 months ]
    measurement with GAT in mm Hg


Secondary Outcome Measures :
  1. change in the number of glaucoma medications compared to baseline [ Time Frame: up to 12 months ]
    accountability of IOP lowering medications used by the patient


Other Outcome Measures:
  1. change of visual acuity compared to baseline [ Time Frame: 6 months and 1 year post-intervention ]
    ETDRS visual acuity scale

  2. change of visual field compared to baseline [ Time Frame: 1 year post-intervention ]
    MD and PSD



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02512133


Locations
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Italy
Ophthalmology Institute, University of Turin
Turin, Italy, 10138
Sponsors and Collaborators
University of Turin, Italy
University of Siena
Investigators
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Principal Investigator: Antonio Fea, MD Clinica Oculistica

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Responsible Party: Antonio Fea, Aggregate Professor, University of Turin, Italy
ClinicalTrials.gov Identifier: NCT02512133     History of Changes
Other Study ID Numbers: 1
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: July 30, 2015
Last Verified: July 2015

Keywords provided by Antonio Fea, University of Turin, Italy:
MIGS
SLT

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases