MIGS VS SLT Comparison in Glaucoma Patients

Glaucoma Clinical Trial

Official title:

MIGS VS SLT in Glaucoma Patients: Prospective Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02512133
• Other study ID #: 1
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 19, 2015
• Last updated: July 29, 2015
• Start date: February 2012
• Est. completion date: July 2017

Study information

• Verified date: July 2015
• Source: University of Turin, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: July 2017
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 80 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• MIGS Hydrus Ivantis
implant of the micro stent in the nasal Schlemm's canal

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

Locations

Country	Name	City	State
Italy	Ophthalmology Institute, University of Turin	Turin

Sponsors (2)

Lead Sponsor	Collaborator
University of Turin, Italy	University of Siena

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change of visual acuity compared to baseline	ETDRS visual acuity scale	6 months and 1 year post-intervention	Yes
Other	change of visual field compared to baseline	MD and PSD	1 year post-intervention	Yes
Primary	change in the intraocular pressure compared to baseline	measurement with GAT in mm Hg	up to 12 months	No
Secondary	change in the number of glaucoma medications compared to baseline	accountability of IOP lowering medications used by the patient	up to 12 months	No